Clinical trial NCT04368325: Low Creatinine Level and Respiratory Failure
Official title: A Correlation of Low Serum Creatinine Levels and Respiratory Function in the Mechanically Ventilated Patients in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit
Respiratory Insufficiency
Muscle Weakness
Keywords: Low serume creatinine levels, respiratory insufficiency, ICU
Lead sponsor: Osijek University Hospital
Sponsor class: OTHER
Collaborators: name: Josip Juraj Strossmayer University of Osijek
First posted: 2020-04-29
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Length of mechanical ventilation treatment in group with low serume creatinine level
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Length of stay in ICU in group with low serume creatinine level
timeFrame: Through study completion, an average of 1 year
measure: White blood cell values in group with low creatinine level
timeFrame: Through study completion, an average of 1 year
measure: Hemoglobine values in group with low creatinine level
timeFrame: Through study completion, an average of 1 year
measure: Number of patients who started nutrition in ICU
timeFrame: Through study completion, an average of 1 year
measure: Platelets values in group with low creatinine level
timeFrame: Through study completion, an average of 1 year
measure: Number of patients who receive blood products transfusion
timeFrame: Through study completion, an average of 1 year
measure: Number of patients discharged
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: University hospital centre Osijek
Study officials:
affiliation: Osijek University Hospital
name: Slavica Kvolik, MD; PhD.
role: STUDY_CHAIR
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