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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Osijek University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Josip Juraj Strossmayer University of Osijek

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 16, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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