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NCT04791566
Preoperative High-dose Dexamethasone and Emergency Laparotomy
Phase 4 trial testing Dexamethasone 1 mg/kg in Intestinal Obstruction and Ileus in 120 participants. Completed in 9 December 2022.
9 October 2022
Quick facts
| Lead sponsor | Mirjana Cihoric |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 March 2021 |
| Primary completion | 9 October 2022 |
| Estimated completion | 9 December 2022 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Dexamethasone 1 mg/kg — full drug profile →
- Physiologic saline — full drug profile →
Conditions studied
- Intestinal Obstruction and Ileus — all drugs for Intestinal Obstruction and Ileus →
- Perforated Viscus — all drugs for Perforated Viscus →
- Sepsis — all drugs for Sepsis →
- Pathophysiology — all drugs for Pathophysiology →
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):
-
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
Verify or expand the search:
- PubMed search for NCT04791566
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04791566 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mirjana Cihoric
- Last refreshed: 14 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04791566.
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