Low Creatinine Level and Respiratory Failure
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| ClinicalTrials.gov Identifier: NCT04368325 |
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Recruitment Status :
Completed
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
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Sponsor:
Osijek University Hospital
Collaborator:
Josip Juraj Strossmayer University of Osijek
Information provided by (Responsible Party):
Osijek University Hospital
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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 |
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 [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
MedlinePlus related topics:
Respiratory Failure
| Group/Cohort | Intervention/treatment |
|---|---|
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Study group
Total of 46 patients with low serum creatinine levels whose values were obtained from the central laboratory with inclusion criteria (< 40mmol/L)
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Diagnostic Test: Serum creatinine levels
Comparison of treatment length using mechanical ventilaton, length of stay in ICU, survival between two groups |
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Control group
A total of 61 consecutive patients were obtained who were treated in ICU CHC Osijek, according to the date of admission.
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Diagnostic Test: Serum creatinine levels
Comparison of treatment length using mechanical ventilaton, length of stay in ICU, survival between two groups |
Primary Outcome Measures :
- 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 :
- 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
- 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
- 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
- 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
- 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
- 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
- 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
| Croatia | |
| University hospital centre Osijek | |
| Osijek, Croatia, 31000 | |
Sponsors and Collaborators
Osijek University Hospital
Josip Juraj Strossmayer University of Osijek
Investigators
| Study Chair: | Slavica Kvolik, MD; PhD. | Osijek University Hospital |
Publications:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Osijek University Hospital:
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Low serume creatinine levels, respiratory insufficiency, ICU |
Additional relevant MeSH terms:
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Muscle Weakness Respiratory Insufficiency Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations |
Neurologic Manifestations Nervous System Diseases Pathologic Processes Respiration Disorders Respiratory Tract Diseases |