Low Creatinine Level and Respiratory Failure

April 27, 2020 updated by: Osijek University Hospital

A Correlation of Low Serum Creatinine Levels and Respiratory Function in the Mechanically Ventilated Patients in the Intensive Care Unit

Low creatinine levels may be a sign of muscle atrophy or weakness, and therefore predictive for respiratory insufficiency in the Intensive care unit (ICU) patients. The investigators compared the outcomes of participants with low creatinine levels with subsequent ICU participants admitted into ICU in the tertiary hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators have found a total of 46 participants with low creatinine levels and compared their outcome data with a group of participants with normal or high creatinine levels (control group, N=61). Low creatinine was defined as values of ≤40 μmol/L. Demographic data, type of admission (medical vs. surgical), hemoglobin values, CRP, and ventilator days were compared. A statistical analysis was performed using chi square and T-test.

Study Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Osijek, Croatia, 31000
        • University Hospital Centre Osijek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study group was selected by measuring low serume creatinine levels (≤40 µmol/L) during the treatment in ICU. Control group was obtained by consecutive selection of patients according to the date of admission to the ICU.

Description

Inclusion Criteria:

  • Inclusion criteria for study group was value of ≤40 µmol/L serume creatinine level during hospitalization in ICU from July 2015 to November 2016.

Exclusion Criteria:

  • Patients who were younger than 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Total of 46 patients with low serum creatinine levels whose values were obtained from the central laboratory with inclusion criteria (< 40mmol/L)
Diagnostic test: Serum creatinine levels
Comparison of treatment length using mechanical ventilaton, length of stay in ICU, survival between two groups
Control group
A total of 61 consecutive patients were obtained who were treated in ICU CHC Osijek, according to the date of admission.
Diagnostic test: Serum creatinine levels
Comparison of treatment length using mechanical ventilaton, length of stay in ICU, survival between two groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of mechanical ventilation treatment in group with low serume creatinine level
Time Frame: Through study completion, an average of 1 year
The investigators compared length of mechanical ventilation treatment between group with low serume creatinine level and control group
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in ICU in group with low serume creatinine level
Time Frame: Through study completion, an average of 1 year
The investigators compared length of stay in ICU between group with low serume creatinine level and control group
Through study completion, an average of 1 year
White blood cell values in group with low creatinine level
Time Frame: Through study completion, an average of 1 year
The investigators compared white blood cell values between group with low creatinine level and control group
Through study completion, an average of 1 year
Hemoglobine values in group with low creatinine level
Time Frame: Through study completion, an average of 1 year
The investigators compared hemoglobine values between group with low creatinine level and control group
Through study completion, an average of 1 year
Number of patients who started nutrition in ICU
Time Frame: Through study completion, an average of 1 year
The investigators compared number of patients between group with low creatinine level and control group who started nutrition in ICU
Through study completion, an average of 1 year
Platelets values in group with low creatinine level
Time Frame: Through study completion, an average of 1 year
The investigators compared platelet values between group with low creatinine level and control group
Through study completion, an average of 1 year
Number of patients who receive blood products transfusion
Time Frame: Through study completion, an average of 1 year
The investigators compared number of patients who received blood products between group with low creatinine level and control group
Through study completion, an average of 1 year
Number of patients discharged
Time Frame: Through study completion, an average of 1 year
The investigators compared number of patients who were discharged from intensive care unit to the ward between group with low creatinine level and control group
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osijek University Hospital

Collaborators

Josip Juraj Strossmayer University of Osijek

Investigators

  • Study Chair: Slavica Kvolik, MD; PhD., Osijek University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 17, 2015

Primary Completion (ACTUAL)

November 4, 2016

Study Completion (ACTUAL)

June 16, 2017

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (ACTUAL)

April 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OsijekUH-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All the data recorded will be available after the manuscript will be published, upon the request by stjepan.grga.milankovic@gmail.com

IPD Sharing Time Frame

After the publication of the manuscript in the medical journal

IPD Sharing Access Criteria

Free available to anyone

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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