Low Creatinine Level and Respiratory Failure

Muscle Weakness Clinical Trial

Official title:

A Correlation of Low Serum Creatinine Levels and Respiratory Function in the Mechanically Ventilated Patients in the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04368325
• Other study ID #: OsijekUH-7
• Status: Completed
• Start date: May 17, 2015
• Est. completion date: June 16, 2017

Study information

• Verified date: April 2020
• Source: Osijek University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 hospital.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: June 16, 2017
• Est. primary completion date: November 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Unit
• Muscle Weakness
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Diagnostic Test:
• Serum creatinine levels
Comparison of treatment length using mechanical ventilaton, length of stay in ICU, survival between two groups

Locations

Country	Name	City	State
Croatia	University hospital centre Osijek	Osijek

Sponsors (2)

Lead Sponsor	Collaborator
Osijek University Hospital	Josip Juraj Strossmayer University of Osijek

Country where clinical trial is conducted

Croatia, 

References & Publications (14)

Briones 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. — View Citation

Coudroy 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. — View Citation

Datta 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. — View Citation

De Jonghe B, Bastuji-Garin S, Durand MC, Malissin I, Rodrigues P, Cerf C, Outin H, Sharshar T; Groupe de Réflexion et d'Etude des Neuromyopathies en Réanimation. Respiratory weakness is associated with limb weakness and delayed weaning in critical illness. Crit Care Med. 2007 Sep;35(9):2007-15. — View Citation

Ellis CS. Improving Nutrition in Mechanically Ventilated Patients. J Neurosci Nurs. 2015 Oct;47(5):263-70; quiz E1. doi: 10.1097/JNN.0000000000000161. Review. — View Citation

Lai 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. — View Citation

Lee 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. — View Citation

Pettenuzzo T, Fan E. 2016 Year in Review: Mechanical Ventilation. Respir Care. 2017 May;62(5):629-635. doi: 10.4187/respcare.05545. Review. — View Citation

Sahetya 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. Review. — View Citation

Schwabbauer 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. — View Citation

van Vught LA, Klein Klouwenberg PM, Spitoni C, Scicluna BP, Wiewel MA, Horn J, Schultz MJ, Nürnberg 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. — View Citation

Vo P, Kharasch VS. Respiratory failure. Pediatr Rev. 2014 Nov;35(11):476-84; quiz 485-6. doi: 10.1542/pir.35-11-476. Review. — View Citation

Weiler 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. — View Citation

Zielinski 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion, an average of 1 year
Secondary	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	Through study completion, an average of 1 year
Secondary	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	Through study completion, an average of 1 year
Secondary	Hemoglobine values in group with low creatinine level	The investigators compared hemoglobine values between group with low creatinine level and control group	Through study completion, an average of 1 year
Secondary	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	Through study completion, an average of 1 year
Secondary	Platelets values in group with low creatinine level	The investigators compared platelet values between group with low creatinine level and control group	Through study completion, an average of 1 year
Secondary	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	Through study completion, an average of 1 year
Secondary	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	Through study completion, an average of 1 year