Acidosis, Renal TubularNCT02392091
Renal Tubular Acidosis is Highly Prevalent in Critically Ill Patients
An observational study of Acidosis, Renal Tubular, run by Medical University of Vienna.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acidosis, Renal Tubular
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients from a medical ICU
Who may be able to join
- 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
Who cannot join
- anuria
About this study
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.
Read the 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.
- Conditions
- Acidosis, Renal Tubular
- Medical subject headings
- Acidosis, Renal Tubular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
renal-tubular acidosis
Diagnosis of renal-tubular acidosis in critically ill patients within 7 days after ICU admission.
Measured: up to 7 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acidosis, Renal TubularStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Brunner, MD, Medical University of Vienna
- Investigators
- Richard Brunner, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392091
- Sponsor's protocol ID
- RTA01
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2015
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Brunner R, Drolz A, Scherzer TM, Staufer K, Fuhrmann V, Zauner C, Holzinger U, Schneeweiss B. Renal tubular acidosis is highly prevalent in critically ill patients. Crit Care. 2015 Apr 6;19(1):148. doi: 10.1186/s13054-015-0890-0.
PubMed 25888397
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Tubular Acidosis is Highly Prevalent in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02392091
- Acronym / sponsor ID
- RTA01
- Conditions
- Acidosis, Renal Tubular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients from a medical ICU
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- anuria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Derived from this study: PubMed 25888397Brunner R, Drolz A, Scherzer TM, Staufer K, Fuhrmann V, Zauner C, Holzinger U, Schneeweiss B. Renal tubular acidosis is highly prevalent in critically ill patients. Crit Care. 2015 Apr 6;19(1):148. doi: 10.1186/s13054-015-0890-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Brunner, MD principal investigator
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
An observational study of Acidosis, Renal Tubular, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal-tubular acidosis (time frame: up to 7 days after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02392091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.