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

Phase 4

Terminated

• Conditions: Kidney Diseases; Postoperative Complications
• Interventions: Drug: Dexamethasone

• Registration Number: NCT03160729
• Lead Sponsor: Rigshospitalet, Denmark

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).

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

Study Timeline

• Study Start: 2017-04-24
• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Primary Completion: 2018-11-23
• Study Completion: 2018-11-23
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Planned open kidney resection, heminephrectomy, nephrectomy Signed informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose	Dexamethasone	Dexamethasone 8 mg
High dose	Dexamethasone	Dexamethasone 24 mg

Primary Outcome Measures

Name	Time	Method
Post-operative complications	24 hours	Complications requiring treatment in the PACU

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark