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Not yet recruiting NCT07359313

Incidence of Colon Ischemia in Patients After Cardiopulmonary Resuscitation (CPR)

No phase Interventional Cardiac Arrest (CA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: colonoscopy.
Who it may be relevant to
Registry conditions: Cardiac Arrest (CA). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Incidence of Colon Ischemia in Patients After Cardiopulmonary Resuscitation (CPR): a Prospective Single-center Epidemiological Incidence Study

Overview

Bedside colonoscopy 24-36 hours after successful CPR

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.

Interventions

  • Procedure colonoscopy
    bedside colonoscopy without bowel cleansing early (24-36h) after successful CPR

Primary outcome measures

  • Detection of colon ischemia [Time frame: from baseline (0 hours) until day 30]
Secondary outcome measures (10)
  • in-hospital mortality [Time frame: from baseline (0 hours) until hospital discharge]
  • abdominal surgery ((hemi-)colectomy) [Time frame: from baseline (0 hours) until hospital discharge]
  • functional outcome [Time frame: day 30, day 60 and day 90]
  • Liver function [Time frame: within 0-72 hours after CPR]
  • renal function [Time frame: within 0-72 hours after CPR]
  • Urine output [Time frame: within 0-72 hours after CPR]
  • Renal replacement therapy [Time frame: from baseline (day 0) until day 30]
  • Serum lactate [Time frame: within 0-72 hours after CPR]
  • SOFA score [Time frame: 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Germany · 1 center
  • Medical Center - University of Freiburg — Freiburg im Breisgau

Identifiers

NCT: NCT07359313 · 24-1320-S1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗