Skip to main content
OpenTrials
Completed

NCT Number: NCT04791566

Preoperative High-dose Dexamethasone and Emergency Laparotomy

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Dexamethasone 1 mg/kg

Drug

Dexamethasone 1 mg/kg administered as a single preoperative i.v. infusion over 10-15 min prior to general anaesthesia

Other names: Dexa-ratiopharm

Physiologic saline

Drug

100 mL Physiologic saline administered as a single preoperative i.v., infusion over 10-15 min prior to general anaesthesia

Primary outcomes

  1. plasma C-reactive protein

    Time frame: 24* hours (*+/- 6 hours) after surgery.

Secondary outcomes

  1. changes in plasma C-reactive protein

    Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 3 and 5

Other outcomes

  1. changes in postoperative inflammatory responses (IL-6, TNF alfa)

    Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5

  2. Change in plasma Syndecain-1sE-Selectin (CD62E)

    Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5

  3. Change in plasma soluble thrombomodulin (sTM)(CD141)

    Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5

  4. Change in plasma sE-Selectin (CD62E)

    Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5

  5. Change in vascular endothelial growth factor (VEGF)

    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

  6. quick Sequential Organ Failure Assessment score, qSOFA

    Time frame: Assessed once preoperatively and 4 times daily during the first 5 postoperative days

  7. Preload dependency via stroke volume(SV) guided resuscitation

    Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5

  8. Fluid distribution, full body water via bioelectrical impedance vector analysis

    Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5

  9. Peak flow measurements

    Time frame: Once a day on postoperative day 1,3 and 5

  10. Postoperative need for antiemetic and analgesic beyond standard course

    Time frame: Once a day during the the first 5 postoperative days

  11. Mobilization, The Cumulated Ambulation Score (CAS)

    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

  12. Postoperative delirium via Confusion Assessment method scale

    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

  13. Postoperative resting pain measured according to Numeric Rating Scale (NRS)

    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

  14. Postoperative pain during mobilization, measured according to Numeric Rating Scale (NRS)

    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

  15. 30-day postoperative mortality

    Time frame: 30 days

  16. 90-day postoperative mortality

    Time frame: 90 days

  17. 30-day postoperative complications

    Time frame: 30 days

  18. Length of ICU stay

    Time frame: 30 days

  19. Overall hospital stay

    Time frame: 30 days

  20. Plasma NO-bioavailability (L-arginine, asymmetric dimethylarginine)

    Time frame: preoperatively, 6 hours after surgery as well as once one postoperative day 1,3 and 5

Sponsors and collaborators

Lead sponsor

Mirjana Cihoric

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2021
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.