Low Serum Creatinine as a Predictor of Prolonged Mechanical Ventilation and Weaning Failure
NCT ID: NCT07177183
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
492 participants
INTERVENTIONAL
2025-10-01
2026-12-31
Brief Summary
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Detailed Description
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Subnormal serum creatinine levels in patients admitted to the post-ICU care unit may have a number of causes, most of which are related to the patient's pre-existing illness, medical interventions in the ICU, or the critical illness itself. It may be related to chronic liver disease (suppressed creatine synthesis) or kidney disease (suppressed creatine synthesis). It may also be a falsely low serum creatinine level caused by fluid overload. Critical illness itself leads to sarcopenia, as a result of which the total amount of creatinine produced in the muscles decreases, and therefore the serum creatinine concentration. Unfortunately, the development of sarcopenia induced by critical illness cannot be influenced therapeutically. Similarly, mitochondrial dysfunction in muscle cells induced by critical illness cannot be influenced therapeutically. This abnormality leads to a decrease in Adenosine Triphosphate (ATP) production and therefore to a decrease in the formation of creatine phosphate, which is the main source for creatinine formation (the conversion of creatine phosphate to creatinine is 3 times faster than the conversion of creatine to creatinine). It is also possible that the subnormal value of serum creatinine is a consequence of an insufficient supply of creatine during nutritional support of critically ill patients in the ICU. Parenteral nutrition does not contain creatine at all, and enteral nutrition are mostly made from milk, which contains only minimal amounts of creatine. This fact creates an environment for the transformation of critically ill patients into the "position of vegetarians", who have demonstrably lower serum creatinine concentrations and also lower muscle strength than "omnivores".
A number of clinical studies have shown that low serum creatinine on admission are associated with higher mortality in patients admitted to the ICU. However, it is not known whether this finding also apply to patients admitted to the post-ICU care unit. Similarly, it is not known whether nutritional support enriched with creatine can improve the outcome of patients admitted to the ICU or to the post-ICU care units. Creatine is a food supplement with significant ergogenic potential and its beneficial effect in these patients is generally expected. The aim of the study is to contribute to clarifying the above-described uncertainties in the knowledge of this issue. The relationship between subnormal serum creatinine od admission and weaning from mechanical ventilation will be investigated through prospective observation, with the assumption that patients with subnormal creatinine levels will have a prolonged weaning compared to patients with normal creatinine values. The methodology of a prospective double-blind, placebo-controlled, randomized clinical trial will be used to investigate the benefit of supplementing nutritional support with creatine in a group of patients with subnormal creatinine value on admission. It is assumed that this procedure will be associated with a reduction in the need for ventilatory support and a better outcome compared to patients who will not receive creatine.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1 (control group)
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.
No intervention
Patients in Group 1 will serve as controls and will receive no intervention, only standard care.
Group 2 (intervention group)
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 creatine
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 3 (intervention group)
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 - placebo
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.
Interventions
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Dietary supplement creatine
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.
Dietary supplement - placebo
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.
No intervention
Patients in Group 1 will serve as controls and will receive no intervention, only standard care.
Eligibility Criteria
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Inclusion Criteria
* Patients admitted to post-ICU care units at Chronicare Group a.s. in the Czech Republic within 12 months
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Roman Kula, MD, CSc
Role: STUDY_CHAIR
University Hospital Ostrava
Locations
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Chronicare Mund s.r.o.
Brno, , Czechia
Chronicare Mund s.r.o.
Brno, , Czechia
Chronicare s.r.o.
Milovice, , Czechia
Chronicare Nord s.r.o.
Ostrava, , Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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KreaTINKA-2025
Identifier Type: -
Identifier Source: org_study_id
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