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NCT04791566

Preoperative High-dose Dexamethasone and Emergency Laparotomy

Completed Phase 4 Last updated 14 December 2022
What this trial tests

Phase 4 trial testing Dexamethasone 1 mg/kg in Intestinal Obstruction and Ileus in 120 participants. Completed in 9 December 2022.

Timeline
1 March 2021
Primary endpoint
9 October 2022
9 December 2022

Quick facts

Lead sponsorMirjana Cihoric
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment120
Start date1 March 2021
Primary completion9 October 2022
Estimated completion9 December 2022
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Mirjana Cihoric — full company profile →

Who can join

18 and older, any sex, with Intestinal Obstruction and Ileus or Perforated Viscus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this trial is to evaluate the effect of high-dose glucocorticoid on inflammatory response and recovery after emergency laparotomy in participants with intestinal obstruction and perforated viscus. Primary outcome is the reduction of C-reactive protein on postoperative day 1. Secondary outcomes are organ specific complications in the post anaesthesia phase, endothel and inflammatory markers, fluid status, preload dependency, pain, lung function, nausea and mobilization during the first 5 days after surgery, . The investigators hypothesize, that a preoperative single high dose of glucocorticoid reduces systemic inflammatory response after emergency laparotomy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Preoperative high dose of dexamethasone in emergency laparotomy: randomized clinical trial.
    Cihoric M, Kehlet H, Lauritsen ML, Højlund J, et al · · 2024 · cited 12× · PMID 39028763 · DOI 10.1093/bjs/znae130

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