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

Postoperative Complications Clinical Trial

— DEX-NEF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03160729
• Other study ID #: DEXNEF01
• Status: Terminated
• Phase: Phase 4
• Start date: April 24, 2017
• Est. completion date: November 23, 2018

Study information

• Verified date: January 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: November 23, 2018
• Est. primary completion date: November 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Postoperative Complications

Intervention

Drug:
• Dexamethasone
pre-operative, single-shot injection

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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