Sepsis survivors monitoring and coordination in outpatient health care (SMOOTH): study protocol for a randomized controlled trial.

BACKGROUND: Sepsis sequelae include critical illness polyneuropathy, myopathy, wasting, neurocognitive deficits, post-traumatic stress disorder, depression and chronic pain. Little is known howlong-term sequelae following hospital discharge are treated. The aim of our study is to determine the effect of a primary care-based, long-term program on health-related quality of life in sepsis survivors. METHODS/DESIGN: In a two-armed randomized multicenter interventional study, patients after sepsis (n = 290) will be assessed at 6, 12 and 24 months. Patients are eligible if severe sepsis or septic shock (ICD-10), at least two criteria of systemic inflammatory response syndrome (SIRS), at least one organ dysfunction and sufficient cognitive capacity are present. The intervention comprises 1) discharge management, 2) training of general practitioners and patients in evidence-based care for sepsis sequelae and 3) telephone monitoring of patients. At six months, we expect an improved primary outcome (health-related quality of life/SF-36) and improved secondary outcomes such as costs, mortality, clinical-, psycho-social- and process-of-care measures in the intervention group compared to the control group. DISCUSSION: This study evaluates a primary care-based, long-term program for patients after severe sepsis. Study results may add evidence for improved sepsis care management. General practitioners may contribute efficiently to sepsis aftercare. TRIAL REGISTRATION: U1111-1119-6345. DRKS00000741, CCT-NAPN-20875 (25 February 2011).

Clinical benefit of power-injectable port systems: a prospective observational study.

OBJECTIVE: To prospectively evaluate the clinical benefit of a central venous port system, which is approved for contrast media injection during contrast enhanced computed tomography. MATERIALS AND METHODS: At a university teaching hospital, 98 patients (59 female, 39 male; median age 61.7 years; range 23-83) had a power-injectable central venous port catheter system implanted. All implantations were performed under ultrasonographic and fluoroscopic guidance by interventional radiologists. Procedure related immediate (up to 24 h after implantation), early (<30 days after implantation) and late complications were documented. The frequency of port system use for contrast enhanced computed tomography scans was also considered. Any port capsule migration was assessed indirectly by determining the catheter tip position. The intended follow-up period was 180 days. RESULTS: An overall complication rate of 0.69 for 1,000 catheter days in 78 evaluated ports was recorded (12 ports affected, 15.4%). During the observational period, 40 of 104 contrast enhanced computed tomography scans were performed utilizing the port for contrast media administration (38.5%). 30 catheter tip retractions of more than 3 cm were observed in 82 patients (36.6%). Overall, tip dislocations were statistically more frequent in the female subgroup. CONCLUSION: The complication rate found in this study is comparable to those, which have been published for standard port systems. The utilization of the device for contrast media injection during contrast enhanced computed tomography scans should be increased. Finally, the port capsule has to be carefully positioned and fixed to prevent migration.

Evaluation of radiologically implanted central venous port systems explanted due to complications.

PURPOSE: The aim of this study was to evaluate explantations of central venous port systems that were implanted by interventional radiologists in cases where complications demanded the removal of the port device. METHODS: In this retrospective single-center study, explantation rates of central venous port catheter systems (CVPS) associated with complications were investigated over a 10-year period. All CVPS were implanted and explanted in our radiology department's interventional suite. Port catheter dysfunctions were divided into early and late complications, as well as into nonthrombotic and thrombotic events. Indications for implantation and explantation as well as clinical demographics were considered. RESULTS: One hundred and ninety-three CVPS were removed from 182 patients, due to complications. The total indwelling time of all CVPS was 55,132 catheter-days (mean 285.7; range 1-2,704). The most common diagnoses were gastrointestinal cancers 77 (39.9%) and hematological malignancies 32 (16.6%). Bloodstream infections 134 (69.4%) were the most common indication for the explantation procedure. These were followed by catheter-related thrombosis 28 (14.5%), nonthrombotic CVPS dysfunction 18 (9.3%), port pocket infections 9 (4.7%), and others 4 (2.1%). The highest percentages of explantations related to bloodstream infections were observed in patients with malabsorption (81.8%) and hematological malignancies (81.3%). CONCLUSION: Bloodstream infections were the most common cause for port explantation, followed by catheter-related thrombosis. Complication-related explantations were mainly for late-onset complications. Prevention and management strategies should be applied regarding care and usage of port systems to reduce the rate of complication-related explantations.

Outcome analysis in 3,160 implantations of radiologically guided placements of totally implantable central venous port systems.

OBJECTIVES: In this retrospective study the success and complication rates after radiologically guided port catheter implantation were evaluated. METHODS: Between 2000 and 2008, 3,160 port catheter systems were implanted in our interventional suite. All interventions were imaging guided. The puncture of the preferably right internal jugular vein (IJV) was ultrasound-assisted and the catheter tip position was controlled with fluoroscopy. Catheter indwelling time and rates of periprocedural, early and late complications were evaluated. RESULTS: 922,599 catheter days (mean, 292 days; range, 0-2,704 days) were documented. The implantation was successful in 3,153 (99.8%) cases. A total of 374 (11.8%; 0.41/1,000 catheter days) adverse events were recorded. Of these, 42 (1.33%) were periprocedural complications. 86 (3.3%; 0.09/1,000 catheter days) early and 246 (9.4%; 0.27/1,000 catheter days) late onset complications occurred after port implantation. The most common complications were blood stream infection (n = 134; 5.1%; 0.15/1,000 catheter days), catheter-induced venous thrombosis (n = 97; 3.7%; 0.11/1,000 catheter days) and catheter migration (n = 34; 1.3%; 0.04/1,000 catheter days). A total of 193 (6.1%) port explantations were required. CONCLUSION: Ultrasound guided port implantation via the IJV results in low periprocedural complication rates.

Double-lumen central venous port catheters: simultaneous application for chemotherapy and parenteral nutrition in cancer patients.

PURPOSE: This study was designed to evaluate the clinical benefit of low-profile double-lumen port catheters in patients receiving simultaneous chemotherapy and parenteral nutrition (PN). Potential advantages, complications, and the durations of simultaneous and single use of the catheter were assessed. METHODS: At a university teaching hospital, 10 patients received a double-lumen port catheter (5 men, 5 women; mean age 61.5 ± 12 years). All port implantations were performed under ultrasonographic and fluoroscopic guidance in the radiologic interventional suite. Procedure-related immediate, early, and late complications were recorded until removal of the device, patient's death, or completion of follow-up period. Application times and durations for chemotherapy or PN were determined. RESULTS: No immediate complications were observed. First use of the port system for chemotherapy was within 12 days (± 25 days, range 0-84 days) and within 17 hours (± 22 hours, range 0-72 hours) for PN on average. During the application of PN, no delay or interruption of chemotherapy was observed. The port catheter was used for the simultaneous application of chemotherapy and PN for a total of 1,216 hours. One port catheter was removed after 30 days due to suspected port infection. CONCLUSION: Central venous double-lumen port systems as a therapeutic option in patients requiring chemotherapy and PN can increase safety during those simultaneous applications, while offering improved patient comfort.