Intensive Care UnitNCT04368325
Low Creatinine Level and Respiratory Failure
An observational study of Intensive Care Unit and Respiratory Insufficiency, run by Osijek University Hospital at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, Respiratory Insufficiency, Muscle Weakness
- What is being tested?
- Serum creatinine levels
- How many people
- 107 participants
- Where
- 1 siteCroatia
- Study dates
- 17 May 2015to 16 Jun 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Inclusion criteria for study group was value of ≤40 µmol/L serume creatinine level during hospitalization in ICU from July 2015 to November 2016.
Who cannot join
- Patients who were younger than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Serum creatinine levels
- Keywords
- Low serume creatinine levels, respiratory insufficiency, ICU
- Medical subject headings
- Respiratory Insufficiency, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum creatinine levelsDiagnostic test
Comparison of treatment length using mechanical ventilaton, length of stay in ICU, survival between two groups
| Study group | Role | What they receive |
|---|---|---|
| Study group | Total of 46 patients with low serum creatinine levels whose values were obtained from the central laboratory with inclusion criteria (< 40mmol/L) Receives: Diagnostic Test: Serum creatinine levels | |
| Control group | A total of 61 consecutive patients were obtained who were treated in ICU CHC Osijek, according to the date of admission. Receives: Diagnostic Test: Serum creatinine levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of mechanical ventilation treatment in group with low serume creatinine level
The investigators compared length of mechanical ventilation treatment between group with low serume creatinine level and control group
Measured: Through study completion, an average of 1 year
Secondary outcomes (7)
Length of stay in ICU in group with low serume creatinine level
The investigators compared length of stay in ICU between group with low serume creatinine level and control group
Measured: Through study completion, an average of 1 year
White blood cell values in group with low creatinine level
The investigators compared white blood cell values between group with low creatinine level and control group
Measured: Through study completion, an average of 1 year
Hemoglobine values in group with low creatinine level
The investigators compared hemoglobine values between group with low creatinine level and control group
Measured: Through study completion, an average of 1 year
Number of patients who started nutrition in ICU
The investigators compared number of patients between group with low creatinine level and control group who started nutrition in ICU
Measured: Through study completion, an average of 1 year
Platelets values in group with low creatinine level
The investigators compared platelet values between group with low creatinine level and control group
Measured: Through study completion, an average of 1 year
Number of patients who receive blood products transfusion
The investigators compared number of patients who received blood products between group with low creatinine level and control group
Measured: Through study completion, an average of 1 year
Number of patients discharged
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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start17 May 2015
- Primary completion4 Nov 2016
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 107 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Josip Juraj Strossmayer University of Osijek
- Responsible party
- Sponsor
- Investigators
- Slavica Kvolik, MD; PhD., Study chair, Osijek University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368325
- Sponsor's protocol ID
- OsijekUH-7
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the data recorded will be available after the manuscript will be published, upon the request by stjepan.grga.milankovic@gmail.com
Publications
Vo P, Kharasch VS. Respiratory failure. Pediatr Rev. 2014 Nov;35(11):476-84; quiz 485-6. doi: 10.1542/pir.35-11-476.
PubMed 25361907Briones Claudett KH. Noninvasive ventilation in the event of acute respiratory failure in patients with idiopathic pulmonary fibrosis: waiting for? J Crit Care. 2014 Dec;29(6):1128. doi: 10.1016/j.jcrc.2014.07.016. Epub 2014 Jul 22. No abstract available.
PubMed 25201432Schwabbauer N, Berg B, Blumenstock G, Haap M, Hetzel J, Riessen R. Nasal high-flow oxygen therapy in patients with hypoxic respiratory failure: effect on functional and subjective respiratory parameters compared to conventional oxygen therapy and non-invasive ventilation (NIV). BMC Anesthesiol. 2014 Aug 7;14:66. doi: 10.1186/1471-2253-14-66. eCollection 2014.
PubMed 25110463Zielinski J, MacNee W, Wedzicha J, Ambrosino N, Braghiroli A, Dolensky J, Howard P, Gorzelak K, Lahdensuo A, Strom K, Tobiasz M, Weitzenblum E. Causes of death in patients with COPD and chronic respiratory failure. Monaldi Arch Chest Dis. 1997 Feb;52(1):43-7.
PubMed 9151520Pettenuzzo T, Fan E. 2016 Year in Review: Mechanical Ventilation. Respir Care. 2017 May;62(5):629-635. doi: 10.4187/respcare.05545.
PubMed 28442589Sahetya S, Allgood S, Gay PC, Lechtzin N. Long-Term Mechanical Ventilation. Clin Chest Med. 2016 Dec;37(4):753-763. doi: 10.1016/j.ccm.2016.07.014. Epub 2016 Oct 14.
PubMed 27842754De Jonghe B, Bastuji-Garin S, Durand MC, Malissin I, Rodrigues P, Cerf C, Outin H, Sharshar T; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Respiratory weakness is associated with limb weakness and delayed weaning in critical illness. Crit Care Med. 2007 Sep;35(9):2007-15. doi: 10.1097/01.ccm.0000281450.01881.d8.
PubMed 17855814Datta D, Foley R, Wu R, Grady J, Scalise P. Can Creatinine Height Index Predict Weaning and Survival Outcomes in Patients on Prolonged Mechanical Ventilation After Critical Illness? J Intensive Care Med. 2018 Feb;33(2):104-110. doi: 10.1177/0885066616648133. Epub 2016 May 13.
PubMed 27179057Lai YC, Ruan SY, Huang CT, Kuo PH, Yu CJ. Hemoglobin levels and weaning outcome of mechanical ventilation in difficult-to-wean patients: a retrospective cohort study. PLoS One. 2013 Aug 28;8(8):e73743. doi: 10.1371/journal.pone.0073743. eCollection 2013.
PubMed 24015310Lee JJ, Waak K, Grosse-Sundrup M, Xue F, Lee J, Chipman D, Ryan C, Bittner EA, Schmidt U, Eikermann M. Global muscle strength but not grip strength predicts mortality and length of stay in a general population in a surgical intensive care unit. Phys Ther. 2012 Dec;92(12):1546-55. doi: 10.2522/ptj.20110403. Epub 2012 Sep 13.
PubMed 22976446Ellis CS. Improving Nutrition in Mechanically Ventilated Patients. J Neurosci Nurs. 2015 Oct;47(5):263-70; quiz E1. doi: 10.1097/JNN.0000000000000161.
PubMed 26348431Coudroy R, Jamet A, Petua P, Robert R, Frat JP, Thille AW. High-flow nasal cannula oxygen therapy versus noninvasive ventilation in immunocompromised patients with acute respiratory failure: an observational cohort study. Ann Intensive Care. 2016 Dec;6(1):45. doi: 10.1186/s13613-016-0151-7. Epub 2016 May 20.
PubMed 27207177Weiler N, Waldmann J, Bartsch DK, Rolfes C, Fendrich V. Outcome in patients with long-term treatment in a surgical intensive care unit. Langenbecks Arch Surg. 2012 Aug;397(6):995-9. doi: 10.1007/s00423-012-0966-0. Epub 2012 Jun 15.
PubMed 22699745van Vught LA, Klein Klouwenberg PM, Spitoni C, Scicluna BP, Wiewel MA, Horn J, Schultz MJ, Nurnberg P, Bonten MJ, Cremer OL, van der Poll T; MARS Consortium. Incidence, Risk Factors, and Attributable Mortality of Secondary Infections in the Intensive Care Unit After Admission for Sepsis. JAMA. 2016 Apr 12;315(14):1469-79. doi: 10.1001/jama.2016.2691.
PubMed 26975785
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Correlation of Low Serum Creatinine Levels and Respiratory Function in the Mechanically Ventilated Patients in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04368325
- Acronym / sponsor ID
- OsijekUH-7
- Keywords
- Low serume creatinine levels, respiratory insufficiency, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Collaborators
- Josip Juraj Strossmayer University of Osijek
- Study start
- 17 May 2015 (actual)
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Serum creatinine levelsTotal of 46 patients with low serum creatinine levels whose values were obtained from the central laboratory with inclusion criteria (< 40mmol/L) |
| Control group | – | Diagnostic Test: Serum creatinine levelsA total of 61 consecutive patients were obtained who were treated in ICU CHC Osijek, according to the date of admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Inclusion criteria for study group was value of ≤40 µmol/L serume creatinine level during hospitalization in ICU from July 2015 to November 2016.
Key exclusion criteria (1 listed)
- Patients who were younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum creatinine levelsComparison of treatment length using mechanical ventilaton, length of stay in ICU, survival between two groups | Diagnostic test | Control group, Study group |
Primary outcome
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
7 secondary outcomes
Length of stay in ICU in group with low serume creatinine level
Time frame: 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
Hemoglobine values in group with low creatinine level
Time frame: 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
Platelets values in group with low creatinine level
Time frame: 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
Number of patients discharged
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Background: PubMed 25361907Vo P, Kharasch VS. Respiratory failure. Pediatr Rev. 2014 Nov;35(11):476-84; quiz 485-6. doi: 10.1542/pir.35-11-476.
- Background: PubMed 25201432Briones Claudett KH. Noninvasive ventilation in the event of acute respiratory failure in patients with idiopathic pulmonary fibrosis: waiting for? J Crit Care. 2014 Dec;29(6):1128. doi: 10.1016/j.jcrc.2014.07.016. Epub 2014 Jul 22. No abstract available.
- Background: PubMed 25110463Schwabbauer N, Berg B, Blumenstock G, Haap M, Hetzel J, Riessen R. Nasal high-flow oxygen therapy in patients with hypoxic respiratory failure: effect on functional and subjective respiratory parameters compared to conventional oxygen therapy and non-invasive ventilation (NIV). BMC Anesthesiol. 2014 Aug 7;14:66. doi: 10.1186/1471-2253-14-66. eCollection 2014.
- Background: PubMed 9151520Zielinski J, MacNee W, Wedzicha J, Ambrosino N, Braghiroli A, Dolensky J, Howard P, Gorzelak K, Lahdensuo A, Strom K, Tobiasz M, Weitzenblum E. Causes of death in patients with COPD and chronic respiratory failure. Monaldi Arch Chest Dis. 1997 Feb;52(1):43-7.
- Background: PubMed 28442589Pettenuzzo T, Fan E. 2016 Year in Review: Mechanical Ventilation. Respir Care. 2017 May;62(5):629-635. doi: 10.4187/respcare.05545.
- Background: PubMed 27842754Sahetya S, Allgood S, Gay PC, Lechtzin N. Long-Term Mechanical Ventilation. Clin Chest Med. 2016 Dec;37(4):753-763. doi: 10.1016/j.ccm.2016.07.014. Epub 2016 Oct 14.
- Background: PubMed 17855814De Jonghe B, Bastuji-Garin S, Durand MC, Malissin I, Rodrigues P, Cerf C, Outin H, Sharshar T; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Respiratory weakness is associated with limb weakness and delayed weaning in critical illness. Crit Care Med. 2007 Sep;35(9):2007-15. doi: 10.1097/01.ccm.0000281450.01881.d8.
- Background: PubMed 27179057Datta D, Foley R, Wu R, Grady J, Scalise P. Can Creatinine Height Index Predict Weaning and Survival Outcomes in Patients on Prolonged Mechanical Ventilation After Critical Illness? J Intensive Care Med. 2018 Feb;33(2):104-110. doi: 10.1177/0885066616648133. Epub 2016 May 13.
- Background: PubMed 24015310Lai YC, Ruan SY, Huang CT, Kuo PH, Yu CJ. Hemoglobin levels and weaning outcome of mechanical ventilation in difficult-to-wean patients: a retrospective cohort study. PLoS One. 2013 Aug 28;8(8):e73743. doi: 10.1371/journal.pone.0073743. eCollection 2013.
- Background: PubMed 22976446Lee JJ, Waak K, Grosse-Sundrup M, Xue F, Lee J, Chipman D, Ryan C, Bittner EA, Schmidt U, Eikermann M. Global muscle strength but not grip strength predicts mortality and length of stay in a general population in a surgical intensive care unit. Phys Ther. 2012 Dec;92(12):1546-55. doi: 10.2522/ptj.20110403. Epub 2012 Sep 13.
- Background: PubMed 26348431Ellis CS. Improving Nutrition in Mechanically Ventilated Patients. J Neurosci Nurs. 2015 Oct;47(5):263-70; quiz E1. doi: 10.1097/JNN.0000000000000161.
- Background: PubMed 27207177Coudroy R, Jamet A, Petua P, Robert R, Frat JP, Thille AW. High-flow nasal cannula oxygen therapy versus noninvasive ventilation in immunocompromised patients with acute respiratory failure: an observational cohort study. Ann Intensive Care. 2016 Dec;6(1):45. doi: 10.1186/s13613-016-0151-7. Epub 2016 May 20.
- Individual participant dataSharing planned: Yes. All the data recorded will be available after the manuscript will be published, upon the request by stjepan.grga.milankovic@gmail.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Slavica Kvolik, MD; PhD. study chair
Osijek University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit and Respiratory Insufficiency, run by Osijek University Hospital at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of mechanical ventilation treatment in group with low serume creatinine level (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04368325, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.