Preoperative High-dose Dexamethasone and Emergency Laparotomy
NCT ID: NCT04791566
Last Updated: 2022-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2021-03-01
2022-12-09
Brief Summary
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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.
Detailed Description
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Pre-operative high-dose glucocorticoids provide reduction in the inflammatory response after surgery, effective pain relief in several major surgical procedures, as well as reducing fatigue, impairing endothelial dysfunction, potentially amend fluid extravasation, edema and dyscoagulation and vasodilation.
However, glucocorticoids have not been assessed in patients with peritonitis or intestinal obstruction, specifically, the impact on pain, fluid dynamics, respiratory as well as endothelial function and mobilization in both obstruction and perforation.
In this study, patients will be randomized to either high dose dexamethason (1 mg /kg) or placebo (0,9% NaCl), administered as a single dose preoperatively. The investigatoris hypothesize that a preoperative single high dose of glucocorticoid reduces systemic inflammatory response after emergency laparotomy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intestinal obstruction, Dexamethasone 1 mg/kg
Dexamethasone 1 mg/kg administered preoperatively as an i.v. infusion over 10-15 minutes
Dexamethasone 1 mg/kg
Dexamethasone 1 mg/kg administered as a single preoperative i.v. infusion over 10-15 min prior to general anaesthesia
Intestinal obstruction, PLACEBO
Physiologic saline, administered preoperatively as an i.v. infusion over 10-15 minutes
Physiologic saline
100 mL Physiologic saline administered as a single preoperative i.v., infusion over 10-15 min prior to general anaesthesia
Perforated viscus, Dexamethasone 1 mg/kg
Dexamethasone 1 mg/kg administered preoperatively as an i.v. infusion over 10-15 minutes
Dexamethasone 1 mg/kg
Dexamethasone 1 mg/kg administered as a single preoperative i.v. infusion over 10-15 min prior to general anaesthesia
Perforated viscus, PLACEBO
Physiologic saline, administered preoperatively as an i.v. infusion over 10-15 minutes
Physiologic saline
100 mL Physiologic saline administered as a single preoperative i.v., infusion over 10-15 min prior to general anaesthesia
Interventions
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Dexamethasone 1 mg/kg
Dexamethasone 1 mg/kg administered as a single preoperative i.v. infusion over 10-15 min prior to general anaesthesia
Physiologic saline
100 mL Physiologic saline administered as a single preoperative i.v., infusion over 10-15 min prior to general anaesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Primary perforated viscus (perforated ulcer, small intestine or colon)
2. Primary intestinal obstruction ( small intestine or colon)
2. Provided verbal and written informed consent
3. Must speak and understand the Danish language
Exclusion Criteria
2. Emergency re-operations after elective surgery owing to paralytic/obstructive ileus, perforated viscus, anastomotic leakage
3. Reoperation owing to fascial separation with no other abdominal pathology identified and sub-acute colorectal cancer-surgery will be excluded from the cohort. Sub-acute surgery is defined as surgery planned within 48 hours.
4. Intestinal Ischemia
5. intraabdominal bleeding
6. Traumas, gynecological, urogenital and other vascular pathology, pregnant participants.
7. Dementia and/or cognitive dysfunction (diagnosed).
8. Participants not oriented in time, place and person
9. Insuline treatment for diabetes mellitus type I and II
10. Current treatment with systemic glucocorticoids or immune suppressive treatment ( apart from inhalation steroids)
11. Allergies to trial medicine
\-
18 Years
ALL
No
Sponsors
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Mirjana Cihoric
OTHER
Responsible Party
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Mirjana Cihoric
MD, Research fellow
Principal Investigators
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Nicolai Bang Foss, Professor
Role: STUDY_DIRECTOR
Dept. of Anaesthesiology and Intensive Care
Locations
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Mirjana Cihoric
Hvidovre, , Denmark
Countries
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References
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Cihoric M, Kehlet H, Lauritsen ML, Hojlund J, Kanstrup K, Karnsund S, Foss NB. Preoperative high dose of dexamethasone in emergency laparotomy: randomized clinical trial. Br J Surg. 2024 Jul 2;111(7):znae130. doi: 10.1093/bjs/znae130.
Other Identifiers
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H-20038432
Identifier Type: -
Identifier Source: org_study_id