Prolonged Mechanical VentilationSECRET-VENTNCT07177183
Low Serum Creatinine as a Predictor of Prolonged Mechanical Ventilation and Weaning Failure
A study testing Dietary supplement creatine in people with Prolonged Mechanical Ventilation and Critical Illness, run by University Hospital Ostrava at 2 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Mechanical Ventilation, Critical Illness
- What is being tested?
- Dietary supplement creatine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 492 participants
- Where
- 2 sitesCzechia
- Study dates
- 2 Feb 2026to 2 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients <18 years of age
- Patients admitted to post-ICU care units at Chronicare Group a.s. in the Czech Republic within 12 months
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia2 sites, 2 recruiting
- Recruiting
Chronicare Mund s.r.o.
Brno, 621 00
Petr Jelínek, MD, Ph.D., 00420775530275, brno@chronicare.cz
Petr Jelínek, MD, Ph.D.
- Recruiting
Chronicare s.r.o.
Milovice, 289 24
Anton Baluch, MD, 00420326550688, milovice@chronicare.cz
Anton Baluch, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Prolonged Mechanical Ventilation, Critical Illness
- Being tested
- Dietary supplement creatine, Dietary supplement - placebo, No intervention
- Keywords
- Prolonged mechanical ventilation, Critical illness, Creatinine, Creatine supplementation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement creatineDietary 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.
Dietary supplement - placeboDietary 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.
No interventionOther
Patients in Group 1 will serve as controls and will receive no intervention, only standard care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Dietary supplement - placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days
Secondary outcomes (5)
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.
Measured: 21 days
Changes in self-sufficiency
Changes in self-sufficiency will be assessed using the Barthel scale.
Measured: 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.
Measured: 21 days
Changes in muscle strength
Changes in muscle strength will be assessed using a hand-held dynamometer.
Measured: 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.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start2 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion2 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Prolonged Mechanical VentilationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomised into three study arms (active treatment, placebo and controls)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roman Kula, MD, CSc, Study chair, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177183
- Sponsor's protocol ID
- KreaTINKA-2025
- Acronym
- SECRET-VENT
- Status last verified
- Feb 2026
- First submitted
- 9 Sep 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no plan to share individual participant data with other researchers. The data may be provided upon reasonable request.
Publications
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.
PubMed 25239988Groeneveld 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.
PubMed 15795816Gala 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.
PubMed 33098051Thongprayoon 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.
PubMed 27998681Thongprayoon 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.
PubMed 27162688Sahin 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.
PubMed 36734702Cartin-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.
PubMed 17948336Bartholomae 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.
PubMed 36185683Fredriksson 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.
PubMed 16803854Klawitter 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.
PubMed 36982590Jiroutkova 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.
PubMed 26699134Yamamoto 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.
PubMed 39810218Lieu 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.
PubMed 17885392Heimburger 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.
PubMed 23144066Assy 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.
PubMed 17134488
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Serum Creatinine as a Predictor of Prolonged Mechanical Ventilation and Weaning Failure
- ClinicalTrials.gov ID
- NCT07177183
- Acronym / sponsor ID
- SECRET-VENT / KreaTINKA-2025
- Conditions
- Prolonged Mechanical Ventilation, Critical Illness
- Keywords
- Prolonged mechanical ventilation, Critical illness, Creatinine, Creatine supplementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 2 Feb 2028 (estimated)
- First posted
- 16 Sep 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The patients will be randomised into three study arms (active treatment, placebo and controls)
| Arm | Type | Receives |
|---|---|---|
| Group 1 (control group) | Active comparator | Other: No interventionPatients 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. |
| Group 2 (intervention group) | Experimental | Dietary Supplement: Dietary supplement creatinePatients 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. |
| Group 3 (intervention group) | Experimental | Dietary Supplement: Dietary supplement - placeboPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients <18 years of age
- Patients admitted to post-ICU care units at Chronicare Group a.s. in the Czech Republic within 12 months
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Dietary supplement creatineDietary 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 | Group 2 (intervention group) |
| Dietary supplement - placeboDietary 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. | Dietary supplement | Group 3 (intervention group) |
| No interventionPatients in Group 1 will serve as controls and will receive no intervention, only standard care. | Other | Group 1 (control group) |
Primary outcome
Ventilator-free hours
Time frame: 21 days
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
5 secondary outcomes
Incidence of newly recorded infections
Time frame: 21 days
Changes in self-sufficiency
Time frame: 21 days
Changes in cognitive status
Time frame: 21 days
Changes in muscle strength
Time frame: 21 days
Creatine tolerance
Time frame: 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 25239988Williamson 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.
- Background: PubMed 15795816Groeneveld 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.
- Background: PubMed 33098051Gala 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.
- Background: PubMed 27998681Thongprayoon 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.
- Background: PubMed 27162688Thongprayoon 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.
- Background: PubMed 36734702Sahin 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.
- Background: PubMed 17948336Cartin-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.
- Background: PubMed 36185683Bartholomae 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.
- Background: PubMed 16803854Fredriksson 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.
- Background: PubMed 36982590Klawitter 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.
- Background: PubMed 26699134Jiroutkova 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.
- Background: PubMed 39810218Yamamoto 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.
- Individual participant dataSharing planned: Undecided. There is no plan to share individual participant data with other researchers. The data may be provided upon reasonable request.
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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.
Roman Kula, MD, CSc study chair
University Hospital Ostrava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement creatine in people with Prolonged Mechanical Ventilation and Critical Illness, run by University Hospital Ostrava at 2 sites in Czechia.
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free hours (time frame: 21 days). 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 NCT07177183, which also lists 17 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 5 Feb 2026.