An interventional study of Dietary supplement creatine and Dietary supplement - placebo in Prolonged Mechanical Ventilation and Critical Illness, sponsored by University Hospital Ostrava. Recruiting at 2 sites in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Treatment
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.
More than 95% of serum creatinine comes from skeletal muscles, where it is formed by non-enzymatic degradation of creatine. Therefore, in patients with normal kidney function, the serum creatinine value closely correlates with muscle mass volume. It is well documented that critically ill patients lose almost 20% of their muscle mass volume during the first 10 days of their stay in the intensive care unit (ICU). At the same time, it is clear that it is from this group of "longer-stay" patients that those who need subsequent intensive care come. From the above, it can be assumed that in some patients admitted to the post-ICU care unit, the admission serum creatinine value may be subnormal due to muscle devastation caused during the stay in the ICU. This assumption was verified by analysing the admission creatinine values in a group of chronically ventilated adult patients admitted to the post-ICU care unit on CHRONICARE GROUP a.s. over five consecutive months. Of the total number of 264 patients, 123 (47%) patients had an admission serum creatinine value in the subnormal range.
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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's planned enrollment of 492 is above the median of 90 across 926 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →University Hospital Ostrava is the lead sponsor of 148 studies on the registry; 50 are open to participants now.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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 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.
Patients in Group 1 will serve as controls and will receive no intervention, only standard care.
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
Time frame: 21 days
Incidence of newly recorded infections
Secondary endpoints of the study will also include monitoring the incidence of newly recorded infections, assessing the level of respiratory effort with the use of a cough assist. The level of respiratory strength when using a cough assist will be assessed by measur-ing "Peak Cough Flow" directly on the device used. This will be assessed on study days 1, 7, 14, and 21 after enrolment. A newly recorded infection will be considered a situation where it was necessary to start a new antibiotic treatment or a situation where it was necessary to escalate an al-ready ongoing antibiotic treatment. The frequency of occurrence of these situations will be assessed daily over a 21-day period.
Time frame: 21 days
Changes in self-sufficiency
Changes in self-sufficiency will be assessed using the Barthel scale.
Time frame: 21 days
Changes in cognitive status
Changes in cognitive status will be assessed using the "ChroniCare Cognitive Orientation Tool (CC-COT)", a non-standardized tool for the assessment of cognition in patients with limited verbal and non-verbal communication. The tool is a modification of the Mini-Cog test that has been adapted for the conditions of the post-ICU care in patients with tracheostomy, ventilator support, and limited verbal and non-verbal communication.
Time frame: 21 days
Changes in muscle strength
Changes in muscle strength will be assessed using a hand-held dynamometer.
Time frame: 21 days
Creatine tolerance
To assess creatine tolerance, the incidence of gastrointestinal discomfort (bloating or diarrhoea) will be monitored daily for 21 days. The incidence of creatinine and cystatin C elevations into the supranormal range will also be monitored on days 7, 14, and 21 after study enrolment.
Time frame: 21 days
28-day mortality
28-day mortality will be monitored as a tertiary outcome measure.
Time frame: 28 days
Plan to share: Undecided — There is no plan to share individual participant data with other researchers. The data may be provided upon reasonable request.
Start is estimated for Feb 2026; primary completion for Dec 2027, 22 months later.
Of 399 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 22 months is close to that.
Counting every sponsor, half of 403 studies reached it within 21 months; a quarter within 12 and three quarters within 40.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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