Endoscopic Measurements of Mitochondrial Oxygen Tension: a dose-finding study

Recruiting

• Conditions: chronic mesenteric ischemia; lack of oxygen of the intestine; 10018031; 10003216

• Registration Number: NL-OMON44385
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

* * 18 years
* Informed consent
* Unremarkable medical history (no gastroenterologic diseases or surgery, no cardiac or pulmonal diseases)
* No gastrointestinal complaints

Exclusion Criteria

* < 18 years
* Unable to give informed consent
* Pregnancy
* Acute or chronic porphyria
* Hypersensitivity for ALA or porphyrin
* Renal impairment (defined as estimated Glomerular Filration Rate (eGFR) < 90 ml/min/1.73m2)
* Liver impairment (defined as > 1.5x Upper Limit of Normal (ULN) of Alanine transaminase (ALT and/or Aspertate transaminase (AST) and/or alkaline phosphatase (ALP) and/or gamma-glutamyltransferase (GGT) and/or bilirubin)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>the minimum effective dose of 5-aminolevulinic acid (Gliolan) for adequate<br /><br>MitoPO2 measurements during upper endoscopy</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>