Intestinal Obstruction and IleusPhase 4NCT04791566
Preoperative High-dose Dexamethasone and Emergency Laparotomy
A Phase 4 study testing Dexamethasone 1 mg/kg and Physiologic saline in people with Intestinal Obstruction and Ileus and Perforated Viscus, run by Mirjana Cihoric at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Obstruction and Ileus, Perforated Viscus, Sepsis
- What is being tested?
- Dexamethasone 1 mg/kg and Physiologic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 9 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Intestinal Obstruction and Ileus, Perforated Viscus, Sepsis, Pathophysiology, Inflammatory Response
- Being tested
- Dexamethasone 1 mg/kg, Physiologic saline
- Medical subject headings
- Intestinal Obstruction, Ileus, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 1 mg/kgDrug
Also called Dexa-ratiopharm
Dexamethasone 1 mg/kg administered as a single preoperative i.v. infusion over 10-15 min prior to general anaesthesia
Physiologic salineDrug
100 mL Physiologic saline administered as a single preoperative i.v., infusion over 10-15 min prior to general anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Intestinal obstruction, Dexamethasone 1 mg/kg | Active comparator | Dexamethasone 1 mg/kg administered preoperatively as an i.v. infusion over 10-15 minutes Receives: Drug: Dexamethasone 1 mg/kg |
| Intestinal obstruction, PLACEBO | Placebo comparator | Physiologic saline, administered preoperatively as an i.v. infusion over 10-15 minutes Receives: Drug: Physiologic saline |
| Perforated viscus, Dexamethasone 1 mg/kg | Active comparator | Dexamethasone 1 mg/kg administered preoperatively as an i.v. infusion over 10-15 minutes Receives: Drug: Dexamethasone 1 mg/kg |
| Perforated viscus, PLACEBO | Placebo comparator | Physiologic saline, administered preoperatively as an i.v. infusion over 10-15 minutes Receives: Drug: Physiologic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma C-reactive protein
Measured: 24* hours (*+/- 6 hours) after surgery.
Secondary outcomes (1)
changes in plasma C-reactive protein
Measured: Preoperatively, 6 hours postoperatively, as well as postoperative day 3 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Mar 2021
- Primary completion9 Oct 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal Obstruction and IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirjana Cihoric
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mirjana Cihoric, Copenhagen University Hospital, Hvidovre
- Investigators
- Nicolai Bang Foss, Professor, Study director, Dept. of Anaesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791566
- Sponsor's protocol ID
- H-20038432
- Status last verified
- Dec 2022
- First submitted
- 3 Mar 2021
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39028763
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04791566
- Acronym / sponsor ID
- H-20038432
- Conditions
- Intestinal Obstruction and Ileus, Perforated Viscus, Sepsis, Pathophysiology, Inflammatory Response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mirjana CihoricUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 9 Oct 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intestinal obstruction, Dexamethasone 1 mg/kg | Active comparator | Drug: Dexamethasone 1 mg/kgDexamethasone 1 mg/kg administered preoperatively as an i.v. infusion over 10-15 minutes |
| Intestinal obstruction, PLACEBO | Placebo comparator | Drug: Physiologic salinePhysiologic saline, administered preoperatively as an i.v. infusion over 10-15 minutes |
| Perforated viscus, Dexamethasone 1 mg/kg | Active comparator | Drug: Dexamethasone 1 mg/kgDexamethasone 1 mg/kg administered preoperatively as an i.v. infusion over 10-15 minutes |
| Perforated viscus, PLACEBO | Placebo comparator | Drug: Physiologic salinePhysiologic saline, administered preoperatively as an i.v. infusion over 10-15 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (18 years or over) undergoing emergency laparotomy (laparotomy or laparoscopy) for following abdominal pathology:
- Provided verbal and written informed consent
- Must speak and understand the Danish language
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone 1 mg/kgAlso: Dexa-ratiopharmDexamethasone 1 mg/kg administered as a single preoperative i.v. infusion over 10-15 min prior to general anaesthesia | Drug | Intestinal obstruction, Dexamethasone 1 mg/kg, Perforated viscus, Dexamethasone 1 mg/kg |
| Physiologic saline100 mL Physiologic saline administered as a single preoperative i.v., infusion over 10-15 min prior to general anaesthesia | Drug | Intestinal obstruction, PLACEBO, Perforated viscus, PLACEBO |
Primary outcome
plasma C-reactive protein
Time frame: 24* hours (*+/- 6 hours) after surgery.
1 secondary outcome
changes in plasma C-reactive protein
Time frame: Preoperatively, 6 hours postoperatively, as well as postoperative day 3 and 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Derived from this study: PubMed 39028763Cihoric 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolai Bang Foss, Professor study director
Dept. of Anaesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone 1 mg/kg and Physiologic saline in people with Intestinal Obstruction and Ileus and Perforated Viscus, run by Mirjana Cihoric at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma C-reactive protein (time frame: 24* hours (*+/- 6 hours) after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04791566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.