- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02392091
Renal Tubular Acidosis is Highly Prevalent in Critically Ill Patients
Study Overview
Status
Conditions
Detailed Description
Hyperchloremic acidosis is frequent in critically ill patients. Renal tubular acidosis (RTA) may contribute to acidemia in the state of hyperchloremic acidosis, but the prevalence of RTA has never been studied in critically ill patients. Therefore, we aimed to investigate the prevalence, type, and possible risk factors of RTA in critically ill patients using a physical-chemical approach.
This prospective, observational trial was conducted in a medical ICU of a university hospital. 100 consecutive critically ill patients at the age ≥18, expected to stay in the ICU for ≥24h, with the clinical necessity for a urinary catheter and the absence of anuria were included.
Base excess subset calculation based on a physical-chemical approach on the first seven days after ICU admission was used to compare the effects of free water, chloride, albumin, and unmeasured anions on the standard base excess. Calculation of the urine osmolal gap (UOG) - as an approximate measure of the unmeasured urine cation ammonium - served as determinate between renal and extra-renal bicarbonate loss in the state of hyperchloremic acidosis.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- admitted to the medical ICU of the Div. of Gastroenterology & Hepatology of the Medical University of vienna
- age ≥18
- expectancy to stay in the ICU ≥24hours
- clinical necessity for a urinary catheter
Exclusion Criteria:
- anuria
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
critically ill patients
critically ill patients at the age ≥18, expected to stay in the ICU for ≥24h, with the clinical necessity for a urinary catheter and the absence of anuria
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
renal-tubular acidosis
Time Frame: up to 7 days after ICU admission
|
Diagnosis of renal-tubular acidosis in critically ill patients within 7 days after ICU admission.
|
up to 7 days after ICU admission
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard Brunner, MD, Medical University of Vienna
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RTA01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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