Health TrialsbyHealthPanel

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

ConditionsProlonged Mechanical VentilationCritical Illness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Ostrava

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients <18 years of age

Patients admitted to post-ICU care units at Chronicare Group a.s. in the Czech Republic within 12 months

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • No intervention

    Other intervention

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

Treatment groups

492 Participants
are divided into 3 treatment groups
Group A: Group 1 (control group)Active comparator 1 intervention
Group B: Group 2 (intervention group)Experimental treatment 1 intervention
Group C: Group 3 (intervention group)Experimental treatment 1 intervention

Trial outcomes

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

Time frame
21 days

Secondary outcomes

1

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
2

Changes in self-sufficiency

Changes in self-sufficiency will be assessed using the Barthel scale.

Time frame
21 days
3

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
4

Changes in muscle strength

Changes in muscle strength will be assessed using a hand-held dynamometer.

Time frame
21 days

Other outcomes

1

28-day mortality

28-day mortality will be monitored as a tertiary outcome measure.

Time frame
28 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Ostrava

Lead sponsor

Source ClinicalTrials.gov
Apply now