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Corticosteroid

Preoperative High-dose Dexamethasone and Emergency Laparotomy

Phase 4
Waitlist Available
Research Sponsored by Mirjana Cihoric
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours after surgery as well as once one postoperative day 1,3 and 5
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

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.

Eligible Conditions
  • Bowel obstruction
  • Perforated Intestine
  • Sepsis
  • Pathophysiology
  • Inflammation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours after surgery as well as once a day one postoperative day 1,3 and 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours after surgery as well as once a day one postoperative day 1,3 and 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Change in vascular endothelial growth factor (VEGF)
Mobilization, The Cumulated Ambulation Score (CAS)
Postoperative delirium via Confusion Assessment method scale
+2 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Intestinal obstruction, Dexamethasone 1 mg/kgActive Control1 Intervention
Dexamethasone 1 mg/kg administered preoperatively as an i.v. infusion over 10-15 minutes
Group II: Perforated viscus, Dexamethasone 1 mg/kgActive Control1 Intervention
Dexamethasone 1 mg/kg administered preoperatively as an i.v. infusion over 10-15 minutes
Group III: Intestinal obstruction, PLACEBOPlacebo Group1 Intervention
Physiologic saline, administered preoperatively as an i.v. infusion over 10-15 minutes
Group IV: Perforated viscus, PLACEBOPlacebo Group1 Intervention
Physiologic saline, administered preoperatively as an i.v. infusion over 10-15 minutes

Find a Location

Who is running the clinical trial?

Mirjana CihoricLead Sponsor
Nicolai Bang Foss, ProfessorStudy DirectorDept. of Anaesthesiology and Intensive Care
~25 spots leftby Dec 2025
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