Trial document




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  DRKS00017624

Trial Description

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Title

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

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Trial Acronym

GIFCIP

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Subarachnoid hemorrhage, traumatic brain injury and cardiogenic shock are diseases that can be life-threatening and might require weeks of intensive medical care. Administration of medication is an essential part of the treatment. According to current practice, the route of drug administration in critically ill patients can be enteral or parenteral depending on the available drug format and vigilance of patients. However, there are many studies in the literature that report a disturbance of gastrointestinal function in critically ill patients. Therefore, the question of whether the enteral route of drug administration in critically ill patients is pharmacokinetically meaningful should be investigated in this study.
For this purpose, a known proton pump inhibitor (Esomeprazole) is used to assess enteral drug uptake in critically ill patients. Serum levels of esomeprazole should be compared between enteral and parenteral administration route in critically ill Patiens and also analyzed in comparison to patients who undergo a selective surgery under general anesthesia.

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Organizational Data

  •   DRKS00017624
  •   2019/07/10
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  •   yes
  •   Approved
  •   10/1/19, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

  •   U1111-1236-6382 
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Health Condition or Problem studied

  •   Subarachnoid hemorrhage
  •   Traumatic brain injury
  •   Cardiogenic shock
  •   S06.0 -  Concussion
  •   I60.0 -  Subarachnoid haemorrhage from carotid siphon and bifurcation
  •   R57.0 -  Cardiogenic shock
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Interventions/Observational Groups

  •   - 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 administration, the capsule is opened and the contents are administered with water. This administration is continued once a day for the duration of in-hospital treatment.
    - In the comparison group and in the target group, the drug is administered once intravenously instead of enterally on the fifth day.
    - In the target group, blood samples are taken on the second, fourth, fifth and on the eighth day of the in-hospital treatment.
    - In the comparison group, blood samples are taken on the second day (on the preoperative day), on the fourth day (on the first postoperative day) and on the fifth day (second postoperative day)
    - On each day, a total of 9 blood samples are collected from a venous catheter at the following points:
    (1) Immediately prior to drug administration
    (2) 30 minutes
    (3) 60 minutes
    (4) 90 minutes
    (5) 2 hours
    (6) 3 hours
    (7) 4 hours
    (8) 6 hours
    (9) 8 hours
    after administration of Esomeprazole.
    - The blood samples are centrifuged on the collection day, the serum is withdrawn and stored at -60 degrees Celsius until analysis of serum level of esomeprazole is undertaken.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

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.

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Secondary Outcome


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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/07/15
  •   44
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional 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.

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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.

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Addresses

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    • Universitätsmedizin Göttingen, Klinik für Neurochirurgie
    • Mr.  Dr. med.  Tammam  Abboud 
    • Robert-Koch-Strasse 40
    • 37075  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen, Klinik für Anästhesiologie
    • Mr.  Prof. Dr. med.  Onnen  Mörer 
    • Robert-Koch-Strasse 40
    • 37075  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen, Klinik für Kardiologie und Pneumologie
    • Mr.  Prof. Dr. med.  Karl  Toischer 
    • Robert-Koch-Strasse 40
    • 37075  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen
    • Mr.  Dr. med.  Tammam  Abboud 
    • Robert-Koch-Strasse 40
    • 37075  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen
    • Mr.  Dr. med  Tammam  Abboud 
    • Robert-Koch-Strasse 40
    • 37075  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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