High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Nephrectomy (DEX-NEF)
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Post-operative complications
Study Overview
Brief 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.
Detailed Description
Post-surgery, patients are traditionally observed and treated in post-anesthesia care units (PACU) until they are discharged to the ward (or directly home) assessed by standardized international discharge criteria.
The research project "Why in PACU?" (Rigshospitalet, Denmark), has since the beginning of 2016 systematically collected and analyzed procedure-related complications in the recovery phase. The complications include pain, nausea/vomiting, circulatory and respiratory problems, orthostatic intolerance and cognitive disorders. Common to all the above-mentioned post-operative problems are the possible links to the inflammatory response caused by the surgical trauma.
Glucocorticoids can in this context be central for the reduction of acute postoperative organ dysfunctions, caused by the anti-inflammatory effect. In a number of different surgical procedures, single dose, pre-operative glucocorticoids have been shown to reduce post-operative nausea and vomiting (PONV), acute pain and need of opioids as well as accelerate the convalescence.
Meta-analyses also showed that single-dose administration of glucocorticoids (methylprednisolone and dexamethasone) for surgical patients is safe as opposed to long-term treatment.
The "Why in PACU?" database shows that 60 % of patients having open kidney surgery have complications in the PACU (primarily pain and hypoxia).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
High dose
Dexamethasone 24 mg
Intervention: Dexamethasone (Drug)
Low dose
Dexamethasone 8 mg
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
Post-operative complications
Time Frame: 24 hours
Complications requiring treatment in the PACU
Secondary Outcomes
- Pain postoperative(4 days)
- Post operative nausea and vomiting (PONV)(4 days)
- Mental status(4 days)
- Length of stay, PACU(24 hours)
- Length of stay, hospital(1 month)
- Discharge score(24 hours)
- Complications(24 hours)
- Analgesics(4 days)
- Antiemetics(4 days)
- Sleep(4 days)
- Wound complications(30 days)
- Readmissions(30 days)
Investigators
Kristin Julia Steinthorsdottir
MD, clinical assistant
Rigshospitalet, Denmark