The Effects of Preoperative High-dose Dexamethasone on Inflammatory Response and Recovery After Emergency Laparotomy, a Randomized, Double-blind, Placebo-controlled Clinical Trial - AHA STEROID TRIAL
Overview
- Phase
- Phase 4
- Intervention
- Dexamethasone 1 mg/kg
- Conditions
- Intestinal Obstruction and Ileus
- Sponsor
- Mirjana Cihoric
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- plasma C-reactive protein
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Mirjana Cihoric
MD, Research fellow
Copenhagen University Hospital, Hvidovre
Eligibility Criteria
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)
Arms & Interventions
Intestinal obstruction, Dexamethasone 1 mg/kg
Dexamethasone 1 mg/kg administered preoperatively as an i.v. infusion over 10-15 minutes
Intervention: Dexamethasone 1 mg/kg
Intestinal obstruction, PLACEBO
Physiologic saline, administered preoperatively as an i.v. infusion over 10-15 minutes
Intervention: Physiologic saline
Perforated viscus, Dexamethasone 1 mg/kg
Dexamethasone 1 mg/kg administered preoperatively as an i.v. infusion over 10-15 minutes
Intervention: Dexamethasone 1 mg/kg
Perforated viscus, PLACEBO
Physiologic saline, administered preoperatively as an i.v. infusion over 10-15 minutes
Intervention: Physiologic saline
Outcomes
Primary Outcomes
plasma C-reactive protein
Time Frame: 24* hours (*+/- 6 hours) after surgery.
Secondary Outcomes
- changes in plasma C-reactive protein(Preoperatively, 6 hours postoperatively, as well as postoperative day 3 and 5)