Preoperative High-dose Dexamethasone and Emergency Laparotomy

  • STATUS
    Recruiting
  • days left to enroll
    84
  • participants needed
    110
  • sponsor
    Mirjana Cihoric
Updated on 25 April 2022
inflammatory response

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.

Description

Surgical trauma and accompanying inflammation results in increased capillary permeability leading to tissue edema. Since the vascular endothelium contributes to homeostasis, endothelial damage may increase the risk of cardiovascular and hemodynamic complications.

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.

Details
Condition Intestinal Obstruction and Ileus, Perforated Viscus, Sepsis, Pathophysiology, Inflammatory Response
Treatment Physiologic saline, Dexamethasone 1 mg/kg
Clinical Study IdentifierNCT04791566
SponsorMirjana Cihoric
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults (18 years or over) undergoing emergency laparotomy (laparotomy or laparoscopy) for following abdominal pathology
Primary perforated viscus (perforated ulcer, small intestine or colon)
Primary intestinal obstruction ( small intestine or colon)
Provided verbal and written informed consent
Must speak and understand the Danish language

Exclusion Criteria

Appendectomies, cholecystectomies, negative diagnostic laparoscopies/laparotomies, herniotomies without bowel resections, sub-acute internal hernias after gastric bypass surgery, sub-acute surgery for inflammatory bowel diseases
Emergency re-operations after elective surgery owing to paralytic/obstructive ileus, perforated viscus, anastomotic leakage
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
Intestinal Ischemia
intraabdominal bleeding
Traumas, gynecological, urogenital and other vascular pathology, pregnant participants
Dementia and/or cognitive dysfunction (diagnosed)
Participants not oriented in time, place and person
Insuline treatment for diabetes mellitus type I and II
Current treatment with systemic glucocorticoids or immune suppressive treatment ( apart from inhalation steroids)
Allergies to trial medicine
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