Cyclosporine microemulsion formulation (sigmasporin microral) effect as first-line immunosuppressant on renal functions at 3 years.

BACKGROUND: Cyclosporine (CsA) remains a mainstay of immunosuppressive maintenance regimens in developing countries, but its effects on long-term kidney allograft survival are still unclear. Our aim was to assess a generic microemulsion CsA (Sigmasporin) for long-term impact on graft function and patient survival among stable renal transplant patients. METHODS: Over a 36-month period, patients with transplantations from >6 months earlier were maintained on CsA doses of 2-8 mg/kg/d to keep C(2) within the recommended therapeutic range. We assessed 25 efficacy and tolerability parameters of scheduled intervals. RESULTS: Twenty-seven patients (9 female, 18 male) from 6 centers in 4 Middle-Eastern countries were enrolled between 2004 and 2009. Their average age was 35.1 ± 9.8 years, body mass index ranged from 15.7 to 41.2 kg/m(2), and average time from transplantation was 2.2 ± 1.6 years. Within the 36-month observation period the CsA dose was reduced by 17.3% from 2.89 ± 0.88 mg/kg/d to achieve C(2) levels of 600-1000 ng/mL. After 36 months the glomerular filtration rate declined by 8.2% from an overall baseline mean of 72.7 ± 23.5 mL/min/1.73 m(2). It improved in 11.1% of patients and remained unchanged in 44.4%. No new cases of hypertension or diabetes mellitus were reported, and there was 1 case of borderline hyperlipidemia. Graft functions were stable, apart from 2 incidences of CsA nephrotoxicity. Both graft and patient 3-year survival rates were 100%. CONCLUSIONS: On a 3-year basis, Sigmasporin Microral was effective to maintain stable renal functions in kidney transplant patients, with safety and tolerability profiles similar to those reported in the international literature.

Six-month clinical outcome of cyclosporine microemulsion formulation (Sigmasporin Microral) in stable renal transplant patients previously maintained on sandimmun neoral.

The trial objective was to investigate the feasibility and safety of conversion to a generic microemulsion cyclosporine in stable renal transplant patients premaintained on Neoral. We enrolled 75 patients from seven centers in five Middle Eastern countries monitored them for 6 months after conversion to Sigmasporin Microral. Readings at 0, 0.5, 1, 2, 3, 4.5, and 6 months included cyclosporine blood level, serum creatinine, liver enzymes, lipid profile, blood sugar, blood pressure and adverse events. Patients included 54 men and 21 women of mean age 38.9 +/- 10.7 years at 30.3 +/- 29.3 months post-transplantation maintained on Sigmasporin Microral dose of 2.8 +/- 1.0 mg/kg per day; they were observed to be stable throughout the study period as reflected by the therapeutic blood C0 level of 181.6 +/- 102.1 and C2 of 759.2 +/- 384.4. Their absorption profile as represented by C2/C0 was 4.9 +/- 2.8, and C2/cyclosporine dose of 282.3 +/- 128.8. An average serum creatinine level of 116.1 +/- 29.5 micromol/L denoted stable graft function and their liver enzymes did not change during the study. No new-onset cases of hypertension, diabetes mellitus, or hyperlipidemia were reported among the patients. Graft function was stable for all patients, except for two incidences of mild acute rejection and two of mild cyclosporine nephrotoxicity; graft and patient survival rates were both 100%. Results of this 6-month study showed that Sigmasporin Microral was effective to maintain stable renal function in kidney transplant patients converted from Neoral with similar safety and tolerability profiles as those reported in the literature.

Therapeutic equivalence and mg:mg switch ability of a generic cyclosporine microemulsion formulation (Sigmasporin Microral) in stable renal transplant patients maintained on Sandimmun Neoral.

We tested a hypothesized pharmacokinetic difference between the reference (Sandimmun Neoral) and test (Sigmasporin Microral) products to prove therapeutic equivalence in an open, multiple fixed dose, one-way crossover, multicenter, and multinational study over a period of 29 days. Forty two stable renal transplant recipients maintained on Sandimmun Neoral were enrolled. Whole blood was collected at day 14 of the study at 0, 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after reference dosing and the same schedule was repeated at day 29 after switching on an mg:mg basis to the test product at day 15 of the study. Analysis of variance was performed for the pharmacokinetic parameters (area under the curve [AUC]0-12, maximum concentration [Cmax]) of cyclosporine using log-transformed values. Tolerability was assessed by vital signs, adverse events, and laboratory investigations. The 90% confidence interval (CI) test for the Ln-transformed, pharmacokinetic parameters was all within the US Food and Drug Administration acceptable range of 80% to 125%, as Ln area under the steady-state curve (AUCss) was within the range of 92.56 to 103.55 and Ln Cmax was within the range of 85.73 to 103.58; the same also applied for AUC0-4, which may be considered the area of greatest inter- and intra-patient variability. Furthermore, in line with the newly adopted recommendations of the Expert Advisory Committee on Bioavailability and Bioequivalence of Health Canada, the 90% CI for AUCss was within the narrow range of 90% to 112%. No significant difference in tolerability was recorded between the two products. Sigmasporin Microral (Julphar) was found to be bioequivalent and clinically interchangeable on an mg:mg basis with Sandimmun Neoral (Novartis).

Successful kidney transplantation does not reverse the coagulopathy in patients with chronic renal failure on either hemo or peritoneal dialysis.

There is wide disagreement about the measurement of various hemostatic parameters in patients with chronic renal failure (CRF) concerning treatment with either hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD). This study aims to characterize the coagulopathy in patients with CRF both before initiating dialysis, when the patients are expected to have a steady hemostatic state and after starting regular HD or CAPD. The measurements were repeated in a group of patients who received a successful renal transplant to see whether the coagulopathy associated with CRF would be corrected by this lasting therapy. The study, which was mainly cross-sectional and prospective, included two groups: 49 patients with CRF with their age ranging from 17 to 67 years were divided as follows: those on regular HD (n=20), CAPD (n=9) and patients after transplant (n=20). The tests were also done on 34 healthy controls. Significant hyper-fibrinogenemia was recorded in all three study groups. The HD group showed significant elevation in the plasma levels of AT III and total protein S and a significant reduction in free protein S and protein C, when compared with healthy controls. These inhibitors, except total PS, displayed similar fluctuations in the CAPD group. In the transplant patients, there was significant elevation of AT III and total protein S, a reduction in free PS and no significant changes in PC levels. A significant elevation was found in the levels of F1+2, TAT and D-Dimer in HD and in transplant patients, when compared with controls. In CAPD patients, only D-Dimer levels showed a significant increase. The tPA and PAI-1 levels in the three study groups were similar to the control group. Our study revealed significant activation of the hemostatic system, more pronounced in patients on HD than CAPD. This coagulopathy remained only partly corrected following successful kidney transplantation.

Platelet surface receptor activation in patients with chronic renal failure on hemodialysis, peritoneal dialysis and those with successful kidney transplantation.

Hemostatic disorders associated with chronic renal failure (CRF) include hemorrhagic and/or thrombotic manifestations, which were ascribed, in part, to uremic platelet dysfunction including abnormalities of expression of platelet glycoprotein receptors. There is, however, still no general agreement on the exact characterization of these platelet abnormalities. This study aims at characterizing the platelet glycoprotein abnormalities associated with CRF, by recording the effect of the three renal replacement therapies, hemodialysis (HD), chronic ambulatory peritoneal dialysis (CAPD), and renal transplantation, on these receptors. The study, which was mainly cross-sectional, included two groups: (i) Patient groups (n = 50): HD patients (n = 20), CAPD patients (n = 10) and successful renal transplant patients (n = 20); (ii) Healthy Controls (n = 34): 23 were men and 11 were women who were age- and sex-matched with the patients. Flow cytometric quantitation of CD41, CD42a, CD42b and CD61 was carried out using a Becton-Dickinson FACScan. The expression of CD41 levels showed a highly significant increase in HD and CAPD patients when compared with the normal control levels. However, levels in transplant patients were comparable to the normal control levels. On the other hand, the expression of CD42a, CD42b, and CD61 showed no significant change in HD and CAPD patients when compared with normal control levels, but there was a significant decrease in transplant patients when compared to the normal control levels. In conclusion, there was evidence of increased expression of one glycoprotein receptor (GpIIb-IIIa) pre-dialysis whether HD or CAPD. In transplant patients, no evidence of platelet activation could be demonstrated.

Serum cystatin C in pregnant women: reference values, reliable and superior diagnostic accuracy.

BACKGROUND: A simple, endogenous, accurate and minimally invasive marker of glomerular filtration rate (GFR) is much desired in clinical nephrology. Cystatin C fulfills all criteria to be a marker for GFR. For early detection of renal impairment in pregnant women, it is necessary to determine serum cystatin C reference values and the correlation with GFR. The present study was therefore undertaken. METHOD: Healthy pregnant women were followed during pregnancy and the postnatal period. Patient demographics included age, height, weight, BMI, parity, total blood count, LFT, urea, creatinine, Na, K, and blood sugar. Serum cystatin C was estimated using particle enhanced nephlo-immunoassay method. All the parameters were recorded at the start of pregnancy and then in each trimester and the postnatal period. Regression analysis correlation coefficient, ANOVA and the Student's t-test were used for analysis using the SPSS statistical package. RESULTS: A total of 197 pregnant women were included. Mean serum cystatin C for all the women was 0.82 +/- 0.184 mg/l. Serum cystatin C levels were high -0.89 +/- 0.12 mg/l in the first trimester, decreased significantly to 0.651 +/- 0.14 mg/l during the second trimester (p = 0.0000 compared to first trimester), and increased again to 0.82 +/- 0.191 mg/l in the third trimester. After delivery the level rose to 0.94 +/- 0.12 mg/l. A strong correlation was found between serum cystatin C and serum creatinine. A strong negative correlation was found between GFR and cystatin C values in the women (r = -0.546, p = 0.000). A linear relationship was found between GFR and cystatin C levels. A significant increase in the GFR was noted with the progression of pregnancy from 128.06 +/- 29.7 ml/min in the first trimester to 155.2 +/- 29.59 ml/min during second trimester (p = 0.006). A decline in the level of cystatin C exactly parallel to the increase in the GFR was noted with the progression of pregnancy. Interestingly cystatin C was found to have a strong negative correlation with gestational age (r = -0.663, p = 0.000). CONCLUSION: Our results indicate that the mean serum cystatin C levels reflect changes in the GFR during the entire pregnancy and also in the postnatal period. Moreover, serum cystatin C levels are independent of age, height, weight, or blood sugar level. Cystatin C can be used for close supervision and early diagnosis of renal impairment in pregnant patients. Cystatin C is a reliable, useful and promising marker of GFR in pregnant women.

Outcome of patients with systemic lupus erythematosus in intensive care unit.

The objective of the study was to identify the causes, outcome and prognosis of severe illness in patients with systemic lupus erythematosus (SLE) requiring intensive care unit (ICU) care in a University Hospital over a five-year period. The design was a cohort study. Forty-eight SLE patients requiring ICU management over a five-year period (January 1997-December 2001) were studied prospectively. Of 48 patients, 14 (29.2%) died, predominantly with multiorgan dysfunction syndrome (MODS). Patients whose APACHE II score was equal to or greater than 20 had higher mortality than those with APACHE score below 20 (60 versus 7.1%; and P < 0.01). All the 18 patients whose health status rated as 'good' survived, while 46.7% of 30 patients whose health rated as 'poor' died (P < 0.01). Patients who had thrombocytopenia associated with sepsis and/or disseminated intravascular coagulopathy (DIC) had the highest mortality (75%, five-year survival). In conclusion, SLE patients admitted to the ICU had a lower mortality rate than some of the previous reports. Patients with SLE with high APACHE score, > or =20, poor health status, thrombocytopenia and multiorgan dysfunction syndrome had poor prognosis in the ICU.

The new rHuEPO alpha (epotin) in the management of anemia of end-stage renal disease in patients on maintenance hemodialysis.

Recombinant human erythropoietin has proved to be effective to treat anemia of end-stage renal disease (ESRD). The aim of this study was to assess the efficacy and safety profile of Epotin, a rHuEPO produced in the Middle East. One hundred thirty patients with Hct

Repeated pregnancies in patients with non-immunoglobulin a mesangioproliferative glomerulonephritis.

AIM: To analyze the effect of repeated pregnancies on underlying MesGN and see the reciprocal effect on maternal and fetal outcome. PATIENTS AND METHODS: Pregnancy records of cases with histological diagnosis of MesGN were reviewed, and past medical histories recorded. RESULTS: Cesarean section (CS). Only two patients developed renal insufficiency after undergoing 5 and 11 pregnancies and follow-up of 9 and 20 years respectively. CONCLUSION: The outcome of repeated pregnancies in patients with MesGN is comparable to normal deliveries. A higher incidence of pre-eclampsia, LBW babies and CS was noted in the post- compared to the pre-MesGN pregnancies. Repeated pregnancies do not influence the course of the MesGN.

Dialyzer reuse impact on dialyzer efficiency, patient morbidity and mortality and cost effectiveness.

Since the introduction of dialyzer reuse more than three decades ago, several studies have reported its safety, efficacy and cost effectiveness. Reuse of hemodialyzer was prospectively studied in ten chronic hemodialysis (HD) patients recruited from the renal unit, the King Khalid University Hospital, Riyadh, Saudi Arabia, for three months. During the study period, 66 dialyzers were used for 408 sessions of HD, with a mean reuse of 6.2 +/- 5.3 episodes per dialyser, the mean of maximum reuse episodes being 13.7 +/- 8.0. The urea reduction ratio was maintained between 73 +/- 5% at baseline to 71.2 +/- 9.03% (p=0.53) at the maximum reuse. Similarly phosphate reduction with each HD session was maintained; mean decrease in phosphate levels was 0.67 mmol/L. Significant increase in heparin requirement was noted; however, the risk of bleeding was not increased. Hematocrit levels increased from 30.4 +/- 4.1% to 33.2 +/- 3.6% at the end of the study (p=0.6). Albumin leak in dialysate decreased with each reuse; baseline 8.27 +/- 7.93 mg/L to 2.8 +/- 0.4 mg/L at maximum reuse (p=0.04). Serum albumin levels remained stable. No short-term adverse effects on patients' morbidity and mortality were noted. Total cost savings of 53% was achieved with the reuse of dialyzers, excluding capital equipment used for preparation for reuse. In conclusion, dialyzer reuse seems to be safe and may provide an economical and efficient dialysis. Studies involving larger number of patients is required to validate this observation.

Effect of intravenous cyclophosphamide pulse therapy on renal functions and histopathology in patients with severe lupus nephritis.

Despite the wide use of intravenous cyclophosphamide (IC) in lupus nephritis (LN), there are few published studies showing the effect of this treatment on renal histology. In this prospective study, we report the effect of IC on the evolution of histopathologic features in successive renal biopsies in patients with LN. Thirty patients with class IV or V LN were started on IC (10-15 mg/kg) administered once every month for six months followed by three monthly for another six doses making a total of two years of therapy. The clinical course of the disease, serum creatinine and 24 hours urinary protein and creatinine clearance were tested at entry and subsequently during each follow-up visit. Repeat renal biopsy was performed after completion of two years of therapy. The mean serum creatinine of the study patients was 166.3 + 42 tmol/L at entry which decreased to 104 + 46.4 tmol/L at two years (P + 2.4 g at entry to 1.39 + 1.54 g at two years (P + 31 ml/min at the start of treatment to 64 + 32 ml/min at two years of therapy (P 200 tmol/L, of whom six progressed to variable degrees of chronic renal failure. Repeat renal biopsy was performed in 21 patients. The original biopsy of these patients showed class IV in 17 and class V in four patients. On repeat biopsy, five of class IV disease had progressed to advanced sclerosis, four to class V, and five remained unchanged. The remaining three patients with class IV LN changed to one each of class I, II and III. Of the four patients with class V, one progressed to advanced sclerosis, one changed to class III and two remained the same. There was a significant decrease (P < 0.05) in the activity index although there was a significant increase in the chronicity index (P < 0.001). Multivariat analysis for possible risk factors for progression to chronic renal failure showed initial high serum creatinine to be a powerful predictor of renal failure. In conclusion, IC pulse therapy is effective in improving or stabilizing renal function in patients with class IV or V LN. The only poor prognostic determinant observed was higher initial serum creatinine value.

Prevalence of glomerular diseases: king khalid university hospital, saudi arabia.

To obtain a more recent and comprehensive insight into the prevalence of glomerular diseases in our patient population, medical records of 200 patients with biopsy proven glomerulonephritis (GN), between January 1994 and June 1999, at the King Khalid University Hospital, Riyadh, Saudi Arabia were analyzed. Primary glomerular disease was found to be the most prevalent, accounting for 63.5% of all glomerular diseases. Among primary glomerular diseases, focal and segmental glomerulosclerosis (FSGS) was the most common histological lesion (34.6%) and was associated with a high prevalence of hypertension (86.4%), nephrotic syndrome (68.18%), hematuria (63.6%) and renal functional impairment (27.3%). Mesangioproliferative GN was the second most common lesion (25.1%) followed by mesangiocapillary GN (15.7%), IgA nephropathy (10.2%), and minimal change disease (8.5%). Amongst secondary glomerular diseases, lupus nephritis was the most prevalent (24.5%). In conclusion, primary glomerular diseases constituted the commonest group encountered and the prevalence of FSGS was quite high with male sex and young adults predominating. FSGS was also associated with a high prevalence of end-stage renal disease. Further collaborative studies are necessary to explore the predisposing factors and associations of glomerular disease, especially FSGS.

The spectrum of glomerulonephritis in saudi arabia: the results of the saudi registry.

Only few studies regarding glomerulonephritis, with relatively small numbers of patients, have so far been published from different centers in Saudi Arabia, and have reported conflicting results regarding the patterns, even in the same city. The possible reasons for these differences include the small number of patients in the different studies, differences in the indications for renal biopsies, referral bias, geographical differences, and, sometimes, the non-availability of the necessary diagnostic facilities in the reporting centers. In order to overcome these problems, a registry for glomerulonephropathy was attempted in Saudi Arabia. Six large referral hospitals from different regions of Saudi Arabia participated in this registry. Biopsy reports and clinical information of 1294 renal biopsies were obtained. There were 782 renal biopsies due to glomerulonephritis (GN) accounting for 77.2% of the total biopsies. Five hundred eighty seven (72.6%) were primary glomerulonephritidis. Focal and segmental glomerulosclerosis (FSGS) (21.3%) and membrano-proliferative glomerulonephritis (MPGN) (20.7%) were the most common types found in the primary glomerulonephritidis. Membranous glomerulonephritis (MGN) was present in only 10.6% of the cases. IgA nephropathy was found in 6.5% of the cases. Of the secondary glomerulo-nephritides, systemic lupus erythematosus (SLE) was the most common indication for biopsy (57.0%) and amyloidosis was found in only 3.2% of the biopsies. In conclusion, FSGS and MPGN were the most common forms of primary glomerulonephritis in adult patients in Saudi Arabia. MGN was not as common as in the western world. SLE was the commonest cause of secondary GN. Amyloidosis was not as common as in other Arab countries. There is a need for more centers from Saudi Arabia to join this national GN registry. Similar registries can be established in different Arab countries, which all would, hopefully, lead to a Pan-Arab GN registry.

Living unrelated renal transplant: outcome and issues.

Living unrelated transplantation (LURT) is emerging as a practical option in renal transplantation due to shortage of living related and cadaver donors. We report a six-years (December 1991 to December 1996) follow-up of 60 LURT patients. The majority of these patients (95%) were transplanted outside the Kingdom of Saudi Arabia; 37 in India, 14 in Egypt, five in the USA and one in Pakistan. Only three patients (emotionally related) were transplanted in Saudi Arabia. Before transplantation, 50 (83.4%) patients were on chronic hemodialysis, three (5%) on peritoneal dialysis and three (5%) were transplanted pre-emptively. Post-operatively, the majority of the study patients were on three drug immunosuppressive therapy. One and five year graft survival was 93.0% and 59.6%, while patient survival at one and three years was 93.7% and 81%, respectively. Surgical complications included lymphocele in 10% of the study patients, urinary leak in 8.3%, and bleeding from the vascular anastomosis in 6.6%. There were eight episodes of acute rejection in eight (13.3%) patients and all episodes were successfully treated; two patients required monoclonal anti-lymphocyte antibodies (OKT3). Eleven (18.3%) patients developed chronic rejection, which resulted in the loss of ten (90%) allografts. Infection was the commonest cause for hospital admission; urinary tract infection (UTI) being responsible for 40% of admissions. Three patients had Cytomegalovirus pneumonia, one had Pneumocystis Carinii pneumonia and one had candida pneumonia. Two (3%) patients developed Kaposi's sarcoma. We conclude that LURT can help in overcoming the shortage of organs for transplant, however, commercial transplantion in developing countries is associated with high morbidity and mortality.

Renal cell carcinoma of contralateral kidney with secondaries in gallbladder eight years after nephrectomy.

A 55-year-old female underwent right nephrectomy for renal cell carcinoma (RCC). The histopathology showed clear cell carcinoma. There was no evidence of metastasis. After remaining asymptomatic for eight years, she developed pain in the right loin. Abdominal ultrasound, computerized tomography (CT) Scan and magnetic resonance imaging (MRI) were suggestive of a tumor mass in the right renal area, multiple tumor masses in the left kidney and a mass in the gallbladder. Cholecystectomy, left radical nephrectomy and right adrenal mass with excision of adjacent lymph nodes were performed. The histopathology from all sites was suggestive of RCC. She was maintained on hemodialysis. Two and half years later she died after surgical exploration for spinal cord decompression due to metastasis to the dorsal spine.

Hepatitis G virus (HGV) infection in Saudi dialysis patients and healthy controls.

BACKGROUND: Viral hepatitis is a global health problem with a high mortality rate. End stage renal disease (ESRD) patients have a high prevalence of Hepatitis B and C virus infection. Present study was done to identify the prevalence and course of a new isolate Hepatitis G virus (HGV) infection in Saudi dialysis patients. METHODS: The pattern of viral hepatitis infection (HBV. HCV and HGV) was investigated in 109 Saudi patients with ESRD and 100 healthy Saudi blood donors. Donated blood was tested for markers of Hepatitis B, C and G viruses. Liver functions were measured and blood picture and liver biopsies were also performed at regular intervals. RESULTS: Out of the 109 ESRD patients 68 (62.4%) were positive for at least one viral marker: 59 (54.1%) were positive for HCV, six (5.5%) were positive for HGV and three (2.8%) were positive for HBsAg. Four of the six HGV positive patients were also co-infected with HCV. Eight (8%) of the blood donors were positive for at least one viral marker. Elevated ALT levels (>4 times normal) were recorded in four out of the six HGV-positive patients including three co-infected with HCV. CONCLUSIONS: Our results are in agreement with similar studies from different countries and also raise the question about the causal relationship between HGV and liver disease among dialysis patients.

Role of interferon-alpha in the treatment of primary glomerulonephritis.

Interferon-alpha (IFN-alpha) is a naturally occurring cytokine. It was the first cytokine used with clinical benefit in the treatment of viral hepatitis and malignancies. Patients with viral hepatitis B or C may have complications with glomerulonephritis (GN). Improvement in proteinuria with or without clearing of viral markers after IFN-alpha therapy has been reported. This encouraged us to offer IFN-alpha therapy to four patients with GN. These patients refused treatment with steroids and/or cyclophosphamide because of concerns about side effects. One patient with membranous GN and two patients with mesangial GN (MesGN) had a remission of nephrotic syndrome. In one patient with type II diabetes and MesGN, renal insufficiency and proteinuria did not subside; however, renal function remained stable. The mechanism of action of IFN-alpha is discussed, with its possible role in the treatment of primary GN.

Acute Hydrothorax Complicating continuous Ambulatory Peritoneal Dialysis: A Case Report and Review of Literature.

We describe here hydrothorax that occurred in a patient on continuous ambulatory peritoneal dialysis (CAPD) and highlight the problems of diagnosis and management. A 48 years-old man with history of obstructive uropathy secondary to urolithiasis was stared on CAPD when he reached end-stage renal failure. Two months later, he was admitted with two days history of shortness of breath on exertion and dry cough increasing in supine position. Chest examination was suggestive of right sided pleural effusion confusion confirmed by chest X-ray. Radioisotope Technetium 99m labeled albumin instilled through the peritoneal catheter was detected in the right pleural fluid confirming the peritoneo-pleural leak. The peritoneal dialysis (PD) was discontinued and the patient was switched to hemodialysis. The pleural effusion subsided and has not recurred for the following three years.

Outcome of early ambulation after renal biopsy using automated biopsy needle by inexperienced trainees.

Percutaneous renal biopsy is a fundamental diagnostic technique. Technical innovations had resulted in an increasing simplicity and safety of the procedure. In this study, 28 kidney biopsies were done using gauge 16 or 18 automated biopsy needle by inexperienced trainees, and patients were allowed full ambulation four hours after biopsy. The trainees failed in 3 (10.7%) attempts. Adequate biopsy was obtained in 89.3%, the mean number of attempts were 2.5 +/- 1.1 (range 1-6/biopsy). The mean length of specimen was 1.5 cm +/- 0.6 (range 0.4-3 cm) and the mean number of glomeruli was 12.8 +/- 7 (range 12-30 glomeruli). Immediately and twenty-four hours after kidney biopsy patients showed no evidence of gross haematuria and ultrasound did not reveal any intrarenal and perirenal haematoma. Microscopic haematuria occurred in 20 (71.4%) patients on the first day and in only 7 (25%) patients the following day. Pain had occurred in 8 (28.5%) patients post-biopsy and in 4 (14.2%) patients on the second day.

Dual-lumen femoral vein catheterization as vascular access for hemodialysis--a prospective study.

Prospectively from January 1991 to January 1993, the efficacy and complications of 104 polyurethane, double-lumen femoral vein catheterizations (FVC) in 96 renal failure patients were studied. Ambulation was allowed in the hospital as well as at home while the catheter was in. There were 53 males and 43 females, with ages ranging from 13 to 87 (mean, 48.3 +/- 19.7) years. Forty-eight patients had chronic renal failure and 48 had acute renal failure. The catheters were used for 1 to 26 days (mean, 8 +/- 5 days). Fifty-two (50%) of the FVC were used for 2 weeks and 14 (13.5%) for 3 weeks or longer. The various complications encountered were infection (n=31), poor blood flow (n=8), displaced catheter (n=6), thrombosis of the catheter (n=4), hematoma (n=4), bleeding (n=3), exit site infection (n=3), ileofemoral vein thrombosis (n=2), and tear in the catheter wall (n=2). On removal, bacterial colonization was present in 34 out of 93 catheter tips (36.5%); Staphylococcus epidermidis (n=12) was the commonest organism grown. There was no significant difference of infection between diabetic and nondiabetic chronic renal failure patients. The duration of catheterization was found to have no relation with either thrombosis or infection. Femoral vein catheters can be used for hemodialysis for 2 to 3 weeks and ambulation during cannulation may be allowed.