IRON NOF trial: IV iron for anaemic patients with femoral fracture.

Background: Preoperative anaemia is associated with increased use of blood transfusions, a greater risk of postoperative complications, and patient morbidity. The IRON NOF trial aimed to investigate whether the administration of i.v. iron in anaemic patients during hip fracture surgery reduced the need for blood transfusion and improved patient outcomes. Methods: This phase III double-blind, randomised, placebo-controlled trial included patients >60 yr old with preoperative anaemia undergoing surgery for femoral neck or subtrochanteric fracture across seven Australian Hospitals. Patients were randomly allocated on a 1:1 basis to receive either i.v. iron carboxymaltose 1000 mg or placebo (saline) at operation. The primary endpoint was blood transfusion use, with secondary endpoints of haemoglobin concentration at 6 weeks, length of hospital stay, rehabilitation duration to discharge, and 6-month mortality. Subgroup analysis compared outcomes in patients <80 yr old and patients >80 yr old. All analyses were performed by intention-to-treat. This trial was terminated early because of jurisdictional changes of more restrictive transfusion practices and changes in consent requirements. Results: Participants (n=143) were recruited between February 2013 and May 2017. There was no difference observed in the incidence of blood transfusion between the treatment group (18/70) (26%) compared with the placebo group (27/73) (37%) (odds ratio for transfusion if receiving placebo: 1.70; 95% confidence interval [CI] 0.83-3.47; P=0.15) and there was no overall difference in the median number of blood units transfused between groups (odds ratio 1.52; 95% CI 0.77-3.00; P=0.22). Patients receiving i.v. iron had a higher haemoglobin 6 weeks after intervention compared with the placebo group (Hb 116 g L-1vs 108 g L-1; P=0.01). No difference was observed in length of hospital stay, rehabilitation duration to discharge, or 6-month mortality. However, in younger patients without major bleeding, the use of placebo compared with i.v. iron was associated with an increased number of units of blood transfused (placebo transfusion incidence rate ratio 3.88; 95% CI 1.16-13.0; P=0.03). Conclusions: In anaemic patients undergoing surgery for hip fracture, i.v. iron did not reduce the overall proportion of patients receiving blood transfusion. The use of i.v. iron may reduce the amount of blood transfused in younger patients. The use of i.v. iron is associated with increased haemoglobin concentrations 6 weeks after the operation. Clinical trial registration: ACTRN12612000448842.

Perioperative outcomes and risk assessment in dialysis patients: current knowledge and future directions.

Perioperative medicine is rapidly emerging as a key discipline to address the specific needs of high-risk surgical groups, such as those on chronic dialysis. Crude hospital separation rates for chronic dialysis patients are considerably higher than patients with normal renal function, with up to 15% of admission being related to surgical intervention. Dialysis dependency carries substantial mortality and morbidity risk compared to patients with normal renal function. This group of patients has a high comorbid burden and complex medical need, making accurate perioperative planning essential. Existing perioperative risk assessment tools are unvalidated in chronic dialysis patients. Furthermore, they fail to incorporate important dialysis treatment-related characteristics that could potentially influence perioperative outcomes. There is a dearth of information on perioperative outcomes of Australasian dialysis patients. Current perioperative outcome estimates stem predominantly from North American literature; however, the generalisability of these findings is limited, as the survival of North American dialysis patients is significantly inferior to their Australasian counterparts and potentially confounds reported perioperative outcomes; let alone regional variation in surgical indication and technique. We propose that data linkage between high-quality national registries will provide more complete data with more detailed patient and procedural information to allow for more informative analyses to develop and validate dialysis-specific risk assessment tools.

Interventions for protecting renal function in the perioperative period.

BACKGROUND: Various methods have been used to try to protect kidney function in patients undergoing surgery. These most often include pharmacological interventions such as dopamine and its analogues, diuretics, calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors, N-acetyl cysteine (NAC), atrial natriuretic peptide (ANP), sodium bicarbonate, antioxidants and erythropoietin (EPO). OBJECTIVES: This review is aimed at determining the effectiveness of various measures advocated to protect patients' kidneys during the perioperative period.We considered the following questions: (1) Are any specific measures known to protect kidney function during the perioperative period? (2) Of measures used to protect the kidneys during the perioperative period, does any one method appear to be more effective than the others? (3) Of measures used to protect the kidneys during the perioperative period,does any one method appear to be safer than the others? SEARCH METHODS: In this updated review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 2, 2012), MEDLINE (Ovid SP) (1966 to August 2012) and EMBASE (Ovid SP) (1988 to August 2012). We originally handsearched six journals (Anesthesia and Analgesia, Anesthesiology, Annals of Surgery, British Journal of Anaesthesia, Journal of Thoracic and Cardiovascular Surgery, and Journal of Vascular Surgery) (1985 to 2004). However, because these journals are properly indexed in MEDLINE, we decided to rely on electronic searches only without handsearching the journals from 2004 onwards. SELECTION CRITERIA: We selected all randomized controlled trials in adults undergoing surgery for which a treatment measure was used for the purpose of providing renal protection during the perioperative period. DATA COLLECTION AND ANALYSIS: We selected 72 studies for inclusion in this review. Two review authors extracted data from all selected studies and entered them into RevMan 5.1; then the data were appropriately analysed. We performed subgroup analyses for type of intervention, type of surgical procedure and pre-existing renal dysfunction. We undertook sensitivity analyses for studies with high and moderately good methodological quality. MAIN RESULTS: The updated review included data from 72 studies, comprising a total of 4378 participants. Of these, 2291 received some form of treatment and 2087 acted as controls. The interventions consisted most often of different pharmaceutical agents, such as dopamine and its analogues, diuretics, calcium channel blockers, ACE inhibitors, NAC, ANP, sodium bicarbonate, antioxidants and EPO or selected hydration fluids. Some clinical heterogeneity and varying risk of bias were noted amongst the studies, although we were able to meaningfully interpret the data. Results showed significant heterogeneity and indicated that most interventions provided no benefit.Data on perioperative mortality were reported in 41 studies and data on acute renal injury in 44 studies (all interventions combined). Because of considerable clinical heterogeneity (different clinical scenarios, as well as considerable methodological variability amongst the studies), we did not perform a meta-analysis on the combined data.Subgroup analysis of major interventions and surgical procedures showed no significant influence of interventions on reported mortality and acute renal injury. For the subgroup of participants who had pre-existing renal damage, the risk of mortality from 10 trials (959 participants) was estimated as odds ratio (OR) 0.76, 95% confidence interval (CI) 0.38 to 1.52; the risk of acute renal injury (as reported in the trials) was estimated from 11 trials (979 participants) as OR 0.43, 95% CI 0.23 to 0.80. Subgroup analysis of studies that were rated as having low risk of bias revealed that 19 studies reported mortality numbers (1604 participants); OR was 1.01, 95% CI 0.54 to 1.90. Fifteen studies reported data on acute renal injury (criteria chosen by the individual studies; 1600 participants); OR was 1.03, 95% CI 0.54 to 1.97. AUTHORS' CONCLUSIONS: No reliable evidence from the available literature suggests that interventions during surgery can protect the kidneys from damage. However, the criteria used to diagnose acute renal damage varied in many of the older studies selected for inclusion in this review, many of which suffered from poor methodological quality such as insufficient participant numbers and poor definitions of end points such as acute renal failure and acute renal injury. Recent methods of detecting renal damage such as the use of specific biomarkers and better defined criteria for identifying renal damage (RIFLE (risk, injury, failure, loss of kidney function and end-stage renal failure) or AKI (acute kidney injury)) may have to be explored further to determine any possible benefit derived from interventions used to protect the kidneys during the perioperative period.

Interventions for protecting renal function in the perioperative period.

BACKGROUND: A number of methods have been used to try to protect kidney function in patients undergoing surgery. These include the administration of dopamine and its analogues, diuretics, calcium channel blockers, angiotensin converting enzyme inhibitors and hydration fluids. OBJECTIVES: For this review, we selected randomized controlled trials which employed different methods to protect renal function during the perioperative period. In examining these trials, we looked at outcomes that included renal failure and mortality as well as changes in renal function tests, such as urine output, creatinine clearance, free water clearance, fractional excretion of sodium and renal plasma flow. SEARCH STRATEGY: We searched the Cochrane Central register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 2), MEDLINE (1966 to June, 2007), and EMBASE (1988 to June, 2007); and handsearched six journals (Anesthesia and Analgesia, Anesthesiology, Annals of Surgery, British Journal of Anaesthesia, Journal of Thoracic and Cardiovascular Surgery, and Journal of Vascular Surgery). SELECTION CRITERIA: We selected all randomized controlled trials in adults undergoing surgery where a treatment measure was used for the purpose of renal protection in the perioperative period. DATA COLLECTION AND ANALYSIS: We selected 53 studies for inclusion in this review. As well as data analysis from all the studies, we performed subgroup analysis for type of intervention, type of surgical procedure, and pre-existing renal dysfunction. We undertook sensitivity analysis on studies with high and moderately good methodological quality. MAIN RESULTS: The review included data from 53 studies, comprising a total of 2327 participants. Of these, 1293 received some form of treatment and 1034 acted as controls. The interventions mostly consisted of different pharmaceutical agents, such as dopamine and its analogues, diuretics, calcium channel blockers, ACE inhibitors, or selected hydration fluids. The results indicated that certain interventions showed minimal benefits. All the results suffered from significant heterogeneity. Hence we cannot draw conclusions about the effectiveness of these interventions in protecting patients' kidneys during surgery. AUTHORS' CONCLUSIONS: There is no reliable evidence from the available literature to suggest that interventions during surgery can protect the kidneys from damage. There is a need for more studies with high methodological quality. One particular area for further study may be patients with pre-existing renal dysfunction undergoing surgery.