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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02392091
Other study ID # RTA01
Secondary ID
Status Completed
Phase N/A
First received March 12, 2015
Last updated March 17, 2015
Start date April 2011
Est. completion date March 2012

Study information

Verified date March 2015
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical Trial Summary

The aim of this study was to investigate the prevalence, type, and possible risk factors of RTA in critically ill patients using a physical-chemical approach.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Outcome

Type Measure Description Time frame Safety issue
Primary renal-tubular acidosis Diagnosis of renal-tubular acidosis in critically ill patients within 7 days after ICU admission. up to 7 days after ICU admission No
See also
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Withdrawn NCT03831152 - Extension Study in Primary Distal Renal Tubular Acidosis Phase 3