Clinical trial NCT03160729: High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Nephrectomy
Official title: High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Nephrectomy (DEX-NEF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Diseases
Postoperative Complications
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative complications
timeFrame: 24 hours
Secondary outcomes:
measure: Length of stay, PACU
timeFrame: 24 hours
measure: Length of stay, hospital
timeFrame: 1 month
measure: Discharge score
timeFrame: 1 hour
measure: Discharge score
timeFrame: 24 hours
measure: Complications
timeFrame: 24 hours
measure: Pain postoperative
timeFrame: 4 days
measure: Analgesics
timeFrame: 4 days
measure: Post operative nausea and vomiting (PONV)
timeFrame: 4 days
measure: Antiemetics
timeFrame: 4 days
measure: Sleep
timeFrame: 4 days
measure: Mental status
timeFrame: 4 days
measure: Wound complications
timeFrame: 30 days
measure: Readmissions
timeFrame: 30 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Kristin J Steinthorsdottir, MD
role: PRINCIPAL_INVESTIGATOR
References: