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

• Status: Terminated
• Trial end date: 2018-11-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

Planned open kidney resection, heminephrectomy, nephrectomy Signed informed consent

Exclusion Criteria:

• chronic/ongoing use of glucocorticoids (except inhalation therapy)

• ongoing use of immunosuppressive therapy

• insulin dependent diabetes

• pregnancy/breastfeeding

• allergies toward study medication, or medication in a standard treatment

• previous kidney resection on same side

• thrombectomy in vena cava above diaphragma

• surgery cannot be performed