Low Serum Creatinine as a Predictor of Prolonged Mechanical Ventilation and Weaning Failure

NCT07177183 | Recruiting

• 1 other identifier: KreaTINKA-2025
• Study Type: interventional
• Target: 492
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of the study is to determine whether a subnormal serum creatinine value upon admission to the Post-ICU Care Unit predicts the need for prolonged ventilatory support. A parallel objective of the study is to determine whether exogenous in-take of the dietary supplement creatine in patients with subnormal serum creatinine value is associated with a shortened duration of ventilatory support and improved patients outcome.

Conditions

Prolonged Mechanical Ventilation; Critical Illness

Keywords

Prolonged mechanical ventilation; Critical illness; Creatinine; Creatine supplementation

Outcome Measures

Primary Outcomes (1)

• Ventilator-free hours

  The primary endpoint of the study will be the "ventilator-free hours", i.e. the total number of hours that the patient was without ventilator support

  21 days

Secondary Outcomes (5)

• Incidence of newly recorded infections

  21 days

• Changes in self-sufficiency

  21 days

• Changes in cognitive status

  21 days

• Changes in muscle strength

  21 days

• Creatine tolerance

  21 days

Other Outcomes (1)

• 28-day mortality

  28 days

Study Arms (3)

Group 1 (control group)

ACTIVE COMPARATOR

Patients with normal baseline serum creatinine value will be enrolled in this group. The care provided to patients in this group will not differ from the usual care provided to other patients.

Other: No intervention

Group 2 (intervention group)

EXPERIMENTAL

Patients with subnormal baseline serum creatinine value will be randomly assigned to group 2 or 3. One group will receive creatine as a dietary supplement and the other will receive placebo. Other care provided to subjects in these groups will not differ from the usual care.

Dietary Supplement: Dietary supplement creatine

Group 3 (intervention group)

EXPERIMENTAL

Patients with subnormal baseline serum creatinine value will be randomly assigned to group 2 or 3. One group will receive creatine as a dietary supplement and the other will receive placebo. Other care provided to subjects in these groups will not differ from the usual care.

Dietary Supplement: Dietary supplement - placebo

Interventions

No intervention OTHER

Patients in Group 1 will serve as controls and will receive no intervention, only standard care.

Group 1 (control group)

Dietary supplement creatine DIETARY_SUPPLEMENT

Dietary supplement creatine. The dosage of creatine will be as follows: for the first 7 days after enrolment, the daily dose will be 2x5g. From days 8 to 21, the daily dose will be 1x5g. The substance will be administered orally or through a nasogastric tube.

Group 2 (intervention group)

Dietary supplement - placebo DIETARY_SUPPLEMENT

Dietary supplement polydextrose as a placebo. The dosage of placebo will be as follows: for the first 7 days after enrolment, the daily dose will be 2x5g. From days 8 to 21, the daily dose will be 1x5g. The substance will be administered orally or through a nasogastric tube.

Group 3 (intervention group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \<18 years of age
• Patients admitted to post-ICU care units at Chronicare Group a.s. in the Czech Republic within 12 months

You may not qualify if:

• Patients who are unlikely to be weaned from ventilatory support.
• Patients in palliative care or with a survival probability of \<3 months
• Patients with advanced malignancy
• Patients with a history of chronic kidney disease
• Patients with a history of chronic liver disease
• Patients with supranormal serum creatinine on admission to the post-ICU care unit
• Patients who refused to sign the Informed Consent with participation in the study.

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (2)

Chronicare Mund s.r.o.

Brno, 621 00, Czechia

RECRUITING

Chronicare s.r.o.

Milovice, 289 24, Czechia

RECRUITING

Related Publications (17)

• Williamson L, New D. How the use of creatine supplements can elevate serum creatinine in the absence of underlying kidney pathology. BMJ Case Rep. 2014 Sep 19;2014:bcr2014204754. doi: 10.1136/bcr-2014-204754.

  PMID: 25239988 BACKGROUND

• Groeneveld GJ, Beijer C, Veldink JH, Kalmijn S, Wokke JH, van den Berg LH. Few adverse effects of long-term creatine supplementation in a placebo-controlled trial. Int J Sports Med. 2005 May;26(4):307-13. doi: 10.1055/s-2004-817917.

  PMID: 15795816 BACKGROUND

• Gala K, Desai V, Liu N, Omer EM, McClave SA. How to Increase Muscle Mass in Critically Ill Patients: Lessons Learned from Athletes and Bodybuilders. Curr Nutr Rep. 2020 Dec;9(4):369-380. doi: 10.1007/s13668-020-00334-0.

  PMID: 33098051 BACKGROUND

• Thongprayoon C, Cheungpasitporn W, Kittanamongkolchai W, Harrison AM, Kashani K. Prognostic Importance of Low Admission Serum Creatinine Concentration for Mortality in Hospitalized Patients. Am J Med. 2017 May;130(5):545-554.e1. doi: 10.1016/j.amjmed.2016.11.020. Epub 2016 Dec 18.

  PMID: 27998681 BACKGROUND

• Thongprayoon C, Cheungpasitporn W, Kashani K. Serum creatinine level, a surrogate of muscle mass, predicts mortality in critically ill patients. J Thorac Dis. 2016 May;8(5):E305-11. doi: 10.21037/jtd.2016.03.62.

  PMID: 27162688 BACKGROUND

• Sahin Tutak A, Aydin H, Findikli HA. Prognostic significance of low basal serum creatinine levels in internal intensive care unit patients. Eur Rev Med Pharmacol Sci. 2023 Jan;27(2):592-600. doi: 10.26355/eurrev_202301_31060.

  PMID: 36734702 BACKGROUND

• Cartin-Ceba R, Afessa B, Gajic O. Low baseline serum creatinine concentration predicts mortality in critically ill patients independent of body mass index. Crit Care Med. 2007 Oct;35(10):2420-3. doi: 10.1097/01.ccm.0000281856.78526.f4.

  PMID: 17948336 BACKGROUND

• Bartholomae E, Knurick J, Johnston CS. Serum creatinine as an indicator of lean body mass in vegetarians and omnivores. Front Nutr. 2022 Sep 16;9:996541. doi: 10.3389/fnut.2022.996541. eCollection 2022.

  PMID: 36185683 BACKGROUND

• Fredriksson K, Hammarqvist F, Strigard K, Hultenby K, Ljungqvist O, Wernerman J, Rooyackers O. Derangements in mitochondrial metabolism in intercostal and leg muscle of critically ill patients with sepsis-induced multiple organ failure. Am J Physiol Endocrinol Metab. 2006 Nov;291(5):E1044-50. doi: 10.1152/ajpendo.00218.2006. Epub 2006 Jun 27.

  PMID: 16803854 BACKGROUND

• Klawitter F, Ehler J, Bajorat R, Patejdl R. Mitochondrial Dysfunction in Intensive Care Unit-Acquired Weakness and Critical Illness Myopathy: A Narrative Review. Int J Mol Sci. 2023 Mar 14;24(6):5516. doi: 10.3390/ijms24065516.

  PMID: 36982590 BACKGROUND

• Jiroutkova K, Krajcova A, Ziak J, Fric M, Waldauf P, Dzupa V, Gojda J, Nemcova-Furstova V, Kovar J, Elkalaf M, Trnka J, Duska F. Mitochondrial function in skeletal muscle of patients with protracted critical illness and ICU-acquired weakness. Crit Care. 2015 Dec 24;19:448. doi: 10.1186/s13054-015-1160-x.

  PMID: 26699134 BACKGROUND

• Yamamoto N, Tojo K, Mihara T, Maeda R, Sugiura Y, Goto T. Creatinine production rate is an integrative indicator to monitor muscle status in critically ill patients. Crit Care. 2025 Jan 14;29(1):23. doi: 10.1186/s13054-024-05222-5.

  PMID: 39810218 BACKGROUND

• Lieu C, Anderson R. Serum creatinine: why lower may not be better. Crit Care Med. 2007 Oct;35(10):2458-9. doi: 10.1097/01.CCM.0000284738.81354.FC. No abstract available.

  PMID: 17885392 BACKGROUND

• Heimburger O, Stenvinkel P, Barany P. The enigma of decreased creatinine generation in acute kidney injury. Nephrol Dial Transplant. 2012 Nov;27(11):3973-4. doi: 10.1093/ndt/gfs459. No abstract available.

  PMID: 23144066 BACKGROUND

• Assy N, Kayal M, Mejirisky Y, Gorenberg M, Hussein O, Schlesinger S. The changes in renal function after a single dose of intravenous furosemide in patients with compensated liver cirrhosis. BMC Gastroenterol. 2006 Nov 29;6:39. doi: 10.1186/1471-230X-6-39.

  PMID: 17134488 BACKGROUND

• Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.

  PMID: 24108501 BACKGROUND

• Kim SW, Jung HW, Kim CH, Kim KI, Chin HJ, Lee H. A New Equation to Estimate Muscle Mass from Creatinine and Cystatin C. PLoS One. 2016 Feb 5;11(2):e0148495. doi: 10.1371/journal.pone.0148495. eCollection 2016.

  PMID: 26849842 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roman Kula, MD, CSc

  University Hospital Ostrava

  STUDY CHAIR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be randomised into three study arms (active treatment, placebo and controls)

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 2, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

CZ (2)