Mirjana Cihoric
Hvidovre, 2650, Denmark
NCT Number: NCT04791566
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Hvidovre, 2650, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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Dexamethasone 1 mg/kg administered as a single preoperative i.v. infusion over 10-15 min prior to general anaesthesia
Other names: Dexa-ratiopharm
100 mL Physiologic saline administered as a single preoperative i.v., infusion over 10-15 min prior to general anaesthesia
Time frame: 24* hours (*+/- 6 hours) after surgery.
Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 3 and 5
Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5
Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5
Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5
Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5
Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5
0 to 1 point: Not high risk; 2 to 3 points: High risk
Time frame: Assessed once preoperatively and 4 times daily during the first 5 postoperative days
Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5
Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5
Time frame: Once a day on postoperative day 1,3 and 5
Time frame: Once a day during the the first 5 postoperative days
Time frame: Once a day on postoperative day 1,3 and 5
The CAS describes the patient's independence with regard to three activities (getting in and out of bed, sit-to-stand-to-sit from a chair, and walking). Each activity is assessed on a three-point ordinal scale from 0-2 (0 = Not able to, despite human assistance and verbal cueing, 1 = Able to, with human assistance and/or verbal cueing from one or more persons, 2 = Able to safely, without human assistance or verbal cueing, use of a walking aid allowed) resulting in a total daily CAS score ranging from zero to six
Time frame: Once a day during the the first 5 postoperative days
1.a: Acute onset
1b: Fluctuating course, 2: inattention 3: disorganized thinking 4: altered level of conciosness At least one criterion must be met for a positive result
Time frame: 6 hours after surgery as well as once a day one postoperative day 1,3 and 5
0-10 where 0 is no pain and 10 is the worst pain imaginable
Time frame: 6 hours after surgery as well as once one postoperative day 1,3 and 5
0-10 where 0 is no pain and 10 is the worst pain imaginable
Time frame: 30 days
Time frame: 90 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: preoperatively, 6 hours after surgery as well as once one postoperative day 1,3 and 5
Mirjana Cihoric
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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