Clinical inter-cohort comparison of gastrointestinal function in critically ill patients.

• Conditions: S06.0; I60.0; R57.0; Concussion; Subarachnoid hemorrhageTraumatic brain injuryCardiogenic shock; Subarachnoid haemorrhage from carotid siphon and bifurcation; Cardiogenic shock

• Registration Number: DRKS00017624
• Lead Sponsor: niversitätsmedizin Göttingen, Klinik für Neurochirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-10
• Study Completion: 2021-07-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Patients in the target or comparison groups described below.
- Administration of proton-pump inhibitor
- Informed consent obtained from patient or his/her legally authorized representative.
- In case of emergency admission, when the patient is unfit to be informed, temporary enrolment is possible after verbal information of the next of kin. Final evaluation of enrolment is required when the patient is legally represented.

Target group

- Patients with subarachnoid hemorrhage Hunt & Hess grade 3-4 or 5, or
- patients with moderate to severe traumatic brain injury as well as
- patients with cardiogenic shock who remain intubated after initial treatment, or require a nasogastric tube for nutrition due to insufficient vigilance.
- Administration of proton-pump inhibitor is indicated in the premedication or due to the onset of the current disease.

Comparison group

- Patients who undergo elective intracranial or cardiac surgery and require postoperative intensive medical care for min. 24 hours.

Exclusion Criteria

- Patients who have Plavix / Clopidogrel in their medication.
- Patient with known benzodiazepine abuse.
- Patients with known chronic bowel disease.
- Patients in the target group who are not admitted within the first 72 hours after the onset of event.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is the assessment of the enteral drug absorption in critically ill patients. This assessment can take place after blood samples have been collected in the enrolled patients by measuring the serum level of esomeprazole in the collected blood samples.<br>Thereafter, the serum levels of esomeprazole are compared in the critically ill patients between enteral and paraenteral administration route and with patients who underwent elective surgery.

Secondary Outcome Measures

Name	Time	Method
<br>Comparison of enteral drug intake between critically ill patients of neurogenic and cardiogenic origin. This comparison can be made after collecting blood samples in those patients by measuring serum levels of esomeprazole.