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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00017624
Enrollment
44
Registered
2019-07-10
Start date
2019-08-08
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid hemorrhage Traumatic brain injury Cardiogenic shock S06.0 I60.0 R57.0

Interventions

Group 1: - All included patients receive on the day of admission an esomeprazole capsule (40mg) which is suitable for both oral administration and gavage administration. For both routes of administrat

Sponsors

Universitätsmedizin Göttingen, Klinik für Neurochirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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. 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

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactTammam Abboud

Universitätsmedizin Göttingen

tammamabboud@gmail.com0551-39-22711

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026