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Low Creatinine Level and Respiratory Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368325
Recruitment Status : Completed
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Collaborator:
Josip Juraj Strossmayer University of Osijek
Information provided by (Responsible Party):
Osijek University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Intensive Care Unit Respiratory Insufficiency Muscle Weakness Diagnostic Test: Serum creatinine levels

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 107 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 12 Months
Official Title: A Correlation of Low Serum Creatinine Levels and Respiratory Function in the Mechanically Ventilated Patients in the Intensive Care Unit
Actual Study Start Date : May 17, 2015
Actual Primary Completion Date : November 4, 2016
Actual Study Completion Date : June 16, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368325


Locations
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Croatia
University hospital centre Osijek
Osijek, Croatia, 31000
Sponsors and Collaborators
Osijek University Hospital
Josip Juraj Strossmayer University of Osijek
Investigators
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Study Chair: Slavica Kvolik, MD; PhD. Osijek University Hospital
Publications:

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Responsible Party: Osijek University Hospital
ClinicalTrials.gov Identifier: NCT04368325    
Other Study ID Numbers: OsijekUH-7
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All the data recorded will be available after the manuscript will be published, upon the request by stjepan.grga.milankovic@gmail.com
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After the publication of the manuscript in the medical journal
Access Criteria: Free available to anyone

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Osijek University Hospital:
Low serume creatinine levels, respiratory insufficiency, ICU
Additional relevant MeSH terms:
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Muscle Weakness
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases