drugset / Trial / NCT03160729

High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Nephrectomy

NCT03160729 ↗

Phase 4 Terminated 45 enrolled Rigshospitalet, Denmark
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this study is to investigate the effect of a single preoperative high-dose steroid injection on complications in the immediate postoperative phase after open kidney surgery (kidney resection, heminephrectomy, nephrectomy). Primary outcome is complications in the post anaesthesia care unit (PACU). Secondary outcomes are organospecific complications in the post anaesthesia phase, pain and nausea the first 5 days, seroma and wound infection the first 14 days and readmissions the first 30 days after surgery. The investigators hypothesize that the frequency of transfer to the PACU and organospecific complications will be lower among patients receiving high dose dexamethasone. The investigators hypothesize, that there will be no difference in wound infections, seroma or readmissions.

Timeline

Start
2017-04-24
Primary completion
2018-11-23
Completion
2018-11-23

Outcome

Outcome not reported

Stopped (Enrollment): “Slow recruitment, schanges in standard treatment”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 8 mg Other
Comparator Dexamethasone Small molecule 24 mg Other

Indications