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

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

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.

Study Overview

• Status: Terminated
• Conditions: Kidney Diseases; Postoperative Complications
• Intervention / Treatment: Drug: Dexamethasone

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: kristin J Steinthorsdottir, MD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): November 23, 2018
• Study Completion (Actual): November 23, 2018

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Kidney Diseases; Postoperative Complications; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: DEXNEF01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No