- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07359313
Incidence of Colon Ischemia in Patients After Cardiopulmonary Resuscitation (CPR)
January 13, 2026 updated by: PD Dr. Alexander Supady, University Hospital Freiburg
Incidence of Colon Ischemia in Patients After Cardiopulmonary Resuscitation (CPR): a Prospective Single-center Epidemiological Incidence Study
Bedside colonoscopy 24-36 hours after successful CPR
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
According to previous observations, many patients after CPR develop acute non-occlusive mesenteric ischemia.
However, due to the lack of established screening strategies, the number of unreported cases may be high.
Routine colonoscopy at 24-36 hours after CPR may be a safe, easy and cost-effective strategy for early detection of severe mesenteric ischemia and transfer to surgical treatment.
However, this strategy has not been formally evaluated in larger prospective cohorts.
In our center, we perform routine colonoscopy at 24 to 36 hours after cardiac arrest in all patients who receive extracorporeal CPR (ECPR), i.e., in all patients with prolonged cardiac arrest refractory to conventional CPR measures who therefore receive venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory support.
In these patients, colonoscopy screening was feasible and safe, and our data suggest clinical benefit.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexander Supady, MD, MPH
- Phone Number: +49-761-270-34010
- Email: alexander.supady@uniklinik-freiburg.de
Study Locations
-
-
-
Freiburg im Breisgau, Germany, 79106
- Medical Center - University of Freiburg
-
Contact:
- Alexander Supady, MD, MPH
- Phone Number: +49-761-270-34010
- Email: alexander.supady@uniklinik-freiburg.de
-
Contact:
- Asieb Sekandarzad, MD
- Phone Number: +49-761-270-34010
- Email: asieb.sekandarzad@uniklinik-freiburg.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- adult patients (≥ 18 years) admitted to the participating department AND
- in-hospital or out-of-hospital cardiac arrest (IHCA, OHCA)
Exclusion Criteria:
- resuscitation period of ≤ 5 minutes
- awake and contactable patients (GCS ≥ 13)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: early colonoscopy after successful CPR
bedside colonoscopy 24-36 hours after successful CPR
|
bedside colonoscopy without bowel cleansing early (24-36h) after successful CPR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of colon ischemia
Time Frame: from baseline (0 hours) until day 30
|
Detection of colon ischemia within 30 days after return of spontaneous circulation
|
from baseline (0 hours) until day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
in-hospital mortality
Time Frame: from baseline (0 hours) until hospital discharge
|
in-hospital mortality
|
from baseline (0 hours) until hospital discharge
|
|
abdominal surgery ((hemi-)colectomy)
Time Frame: from baseline (0 hours) until hospital discharge
|
number of patients requiring/receiving abdominal surgery ((hemi-)colectomy)
|
from baseline (0 hours) until hospital discharge
|
|
functional outcome
Time Frame: day 30, day 60 and day 90
|
Cerebral Performance Category (CPC)
|
day 30, day 60 and day 90
|
|
Liver function
Time Frame: within 0-72 hours after CPR
|
Liver function parameters: Quick/INR, AST, ALT, AP, g-GT
|
within 0-72 hours after CPR
|
|
renal function
Time Frame: within 0-72 hours after CPR
|
Renal function parameters: creatinine, BUN
|
within 0-72 hours after CPR
|
|
Urine output
Time Frame: within 0-72 hours after CPR
|
Urine output (ml)
|
within 0-72 hours after CPR
|
|
Renal replacement therapy
Time Frame: from baseline (day 0) until day 30
|
Implementation of renal replacement therapy within 30 days after return of spontaneous circulation
|
from baseline (day 0) until day 30
|
|
Serum lactate
Time Frame: within 0-72 hours after CPR
|
Serum lactate
|
within 0-72 hours after CPR
|
|
SOFA score
Time Frame: at 0 hours, 24 hours, 48 hours, 72 hours after CPR
|
SOFA
|
at 0 hours, 24 hours, 48 hours, 72 hours after CPR
|
|
SAPS II score
Time Frame: at 0 hours, 24 hours, 48 hours, 72 hours after CPR
|
SAPS II
|
at 0 hours, 24 hours, 48 hours, 72 hours after CPR
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 7, 2026
Primary Completion (Estimated)
January 6, 2028
Study Completion (Estimated)
February 6, 2028
Study Registration Dates
First Submitted
December 19, 2025
First Submitted That Met QC Criteria
January 13, 2026
First Posted (Actual)
January 22, 2026
Study Record Updates
Last Update Posted (Actual)
January 22, 2026
Last Update Submitted That Met QC Criteria
January 13, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Heart Diseases
- Intestinal Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Peritoneal Diseases
- Heart Arrest
- Mesenteric Ischemia
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Minimally Invasive Surgical Procedures
- Diagnostic Techniques, Surgical
- Endoscopy, Gastrointestinal
- Endoscopy, Digestive System
- Diagnostic Techniques, Digestive System
- Endoscopy
- Digestive System Surgical Procedures
- Colonoscopy
Other Study ID Numbers
- 24-1320-S1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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