Jan T. Bottema

Selective decontamination of the digestive tract to prevent postoperative infection: a randomized placebo-controlled trial in liver transplant patients.

ObjectiveTo determine the efficacy of selective decontamination of the digestive tract (SDD) in patients undergoing elective transplantation of the liver. DesignRandomized, double-blind, placebo-controlled study. SettingTwo academic teaching hospitals. PatientsAdult patients undergoing elective liver transplantation: 26 patients receiving SDD and 29 patients receiving a placebo. InterventionsPatients undergoing SDD were administered 400 mg of norfloxacin once daily as soon as they were accepted for transplantation. Postoperative treatment for this group consisted of 2 mg of colistin, 1.8 mg of tobramycin, and 10 mg of amphotericin B, four times daily, combined with an oral paste containing a 2% solution of the same drugs until postoperative day 30. Prophylactic intravenous administration of antibiotics was not part of the SDD regimen in this study. Control patients were given a similar regimen with placebo drugs. MeasurementsThe mean number of postoperative bacterial and fungal infections in the first 30 days after transplantation was the primary efficacy end point. Days on a ventilator, days spent in the intensive care unit, and medical costs were registered as secondary outcome variables. Main ResultsOf the 26 patients undergoing SDD, 22 (84.5%) developed an infection in the postoperative study period; in the placebo group (n = 29), these numbers were not significantly different (25 patients, 86%). The mean number of postoperative infectious episodes per patient was also not significantly different: 1.77 (SDD) vs. 1.93 (placebo). Infections involving Gram-negative aerobic bacteria and Candida species were significantly less frequent in patients receiving SDD (p < .001 and p < .05). Total costs were higher in the group receiving SDD. ConclusionsSelective decontamination of the digestive tract does not prevent infection in patients undergoing elective liver transplantation and increases the cost of their care. It does, however, affect the type of infection. Infections with Gram-negative bacilli and with Candida species are replaced by infections with Gram-positive cocci.

The price of donation after cardiac death in liver transplantation: a prospective cost-effectiveness study.

This study aims to perform a detailed prospective observational multicenter cost‐effectiveness study by comparing liver transplantations with Donation after Brain Death (DBD) and Donation after Cardiac Death (DCD) grafts. All liver transplantations in the three Dutch liver transplant centers between 2004 and 2009 were included with 1‐year follow‐up. Primary outcome parameter was cost per life year after transplantation. Secondary outcome parameters were 1‐year patient and graft survival, complications, and patient‐level costs. From 382 recipients that underwent 423 liver transplantations, 293 were primarily transplanted with DBD and 89 with DCD organs. Baseline characteristics were not different between both groups. The Donor Risk Index was significantly different as were cold and warm ischemic time. Ward stay was significantly longer in DCD transplantations. Patient and graft survival were not significantly different. Patients receiving DCD organs had more and more severe complications. The cost per life year for DBD was € 88 913 compared to € 112 376 for DCD. This difference was statistically significant. DCD livers have more and more severe complications, more reinterventions and consequently higher costs than DBD livers. However, patient and graft survival was not different in this study. Reimbursement should be differentiated to better accommodate DCD transplantations.

Cost Effectiveness of Selective Decontamination of the Digestive Tract in Liver Transplant Patients

AbstractObjective: To assess the cost effectiveness of selective decontamination of the digestive tract (SDD) in liver transplant patients. Design: Randomised, placebo-controlled, double-blind trial with an integrated economic evaluation. Setting: Two university hospitals in The Netherlands. Cost effectiveness was assessed from a societal perspective. Patients and participants: 58 patients who underwent liver transplantation and received SDD (n = 29) or placebo (n = 29) pre- and postoperatively. Interventions: SDD medication and placebo. Main outcome measures: Infection episodes, days of infection, costs of SDD and routine cultures, mean other direct medical costs per patient and additional costs of severe infection. Results: Costs of SDD medicine and routine cultures were on average 3100 US dollars (

A comparison of Percutaneous femoral access in Endovascular Repair versus Open femoral access (PiERO): study protocol for a randomized controlled trial

US; 1997 values) per patient who underwent SDD. Both preoperatively and postoperatively, costs other than SDD and cultures did not significantly differ between the SDD and the placebo groups (preoperative,

Clinical outcome, proteome kinetics and angiogenic factors in serum after thermoablation of colorectal liver metastases

US2370 vs

Percutaneous versus open access in endovascular aneurysm repair (PiERO): A randomized multicenter clinical trial

US2590; postoperative,

Is There an Increased Risk of Bilairy Complications When Using Livers from Elderly Donors for Transplantation? Results of a Dutch Multi-Center Study.

US25 455 vs

Quantification of ABO Blood Group Related Disparities in Liver Transplant Waiting List Mortality in the MELD Era

US24 915). Additional postoperative costs of severe infections were

Donation after Cardiac Death Versus Donation after Brain Death in Liver Transplantation

US250 per day per patient. There were no significant differences in the mean number of infection episodes between groups. Conclusions: SDD leads to the additional costs of SDD medication and routine cultures, whereas no savings in other costs and no improvement in infection episodes are realised. Consequently, SDD may be considered as a nonefficient approach in patients undergoing liver transplantation. The additional costs of severe infection are considerable.

Donation after Cardiac Death Versus Donation after Brain Death in Liver Transplantation : A Cost and Outcome Study

BackgroundAccess for endovascular repair of abdominal aortic aneurysms (EVAR) is obtained through surgical cutdown or percutaneously. The only devices suitable for percutaneous closure of the 20 French arteriotomies of the common femoral artery (CFA) are the Prostar™ and Proglide™ devices (Abbott Vascular). Positive effects of these devices seem to consist of a lower infection rate, and shorter operation time and hospital stay. This conclusion was published in previous reports comparing techniques in patients in two different groups (cohort or randomized). Access techniques were never compared in one and the same patient; this research simplifies comparison because patient characteristics will be similar in both groups.Methods/DesignPercutaneous access of the CFA is compared to surgical cutdown in a single patient; in EVAR surgery, access is necessary in both groins in each patient. Randomization is performed on the introduction site of the larger main device of the endoprosthesis. The contralateral device of the endoprosthesis is smaller. When we use this type of randomization, both groups will contain a similar number of main and contralateral devices. Preoperative nose cultures and perineal cultures are obtained, to compare colonization with postoperative wound cultures (in case of a surgical site infection). Furthermore, patient comfort will be considered, using VAS-scores (Visual analog scale). Punch biopsies of the groin will be harvested to retrospectively compare skin of patients who suffered a surgical site infection (SSI) to patients who did not have an SSI.DiscussionThe PiERO trial is a multicenter randomized controlled clinical trial designed to show the consequences of using percutaneous access in EVAR surgery and focuses on the occurrence of surgical site infections.Trial registrationNTR4257 10 November 2013, NL44578.042.13.