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

Study Overview
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Brief Summary
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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
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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). Based on positive results in other procedure-specific studies, all donor-nephrectomy patients at Rigshospitalet, have received pre-operative high-dose steroids, in the form of 24 mg dexamethasone injection since mid-2015. This has resulted in a reduction of pain requiring treatment with 30 %. Prior to creating clinical recommendations and standards, it is required that the results be tested in a randomized, controlled, clinical trial. The study is not placebo-controlled since the positive effects of dexamethasone 8 mg on PONV have been shown in numerous trials, and is already being administered to all patients at the clinic. It would therefore not be ethically correct to withdraw from this practise

Official Title
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High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Nephrectomy (DEX-NEF)

Conditions
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Kidney Diseases, Postoperative Complications

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose<br>Dexamethasone 24 mg | Drug: Dexamethasone<br>* pre-operative, single-shot injection<br>|
| Active Comparator: Low dose<br>Dexamethasone 8 mg | Drug: Dexamethasone<br>* pre-operative, single-shot injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complications | Complications requiring treatment in the PACU | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay, PACU | Total length of stay in PACU | 24 hours | 
| Length of stay, hospital | Total length of stay in hospital | 1 month | 
| Discharge score | Discharge score (according to discharge criteria) in the operating theater | 1 hour | 
| Discharge score | Discharge score (according to discharge criteria) in the PACU | 24 hours | 
| Complications | Complications requiring treatment in the ward | 24 hours | 
| Pain postoperative | Self-reported pain (worst and average, days 0-4). Questionnaire. | 4 days | 
| Analgesics | Self-reported use of pain medication other than standard treatment (days 0-4). Questionnaire. | 4 days | 
| Post operative nausea and vomiting (PONV) | Self-reported ponv (worst and average, days 0-4. Questionnaire. | 4 days | 
| Antiemetics | Use of antiemetics other than standard treatment (days 0-4. Questionnaire. | 4 days | 
| Sleep | Self-reported quality of sleep (days 0-4). Questionnaire. | 4 days | 
| Mental status | Self-reported feelings of anxiety, unrest, sadness (days 0-4). Questionnaire. | 4 days | 
| Wound complications | Wound complications/infections | 30 days | 
| Readmissions | Any readmissions | 30 days |