CoronavirusNPIDRA2021NCT06226428
Cyclo-Ergometry in the Patient With Acute Respiratory Distress Syndrome
A study testing Bed cyclo-ergonometry, Bed mobility activities (turning, pelvic elevation and sitting), standing, transfers and walking. and Progressive upper and lower limb strength training in people with Coronavirus, run by Biogipuzkoa Health Research Institute at 1 site in Spain.
Trial summary
In March 2020 the World Health Organization declares the Coronavirus disease pandemic 2019. Intensive Care Units deal entirely with patients with pneumonia complicated by Acute Respiratory Distress Syndrome, requiring aggressive respiratory treatments with long periods of connection to mechanical ventilation, sedation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus
- What is being tested?
- Bed cyclo-ergonometry, Bed mobility activities (turning, pelvic elevation and sitting), standing, transfers and walking. and Progressive upper and lower limb strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to 18 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient 18 years of age or older
- Alert and cooperative (RASS agitation-sedation between -1 and +1).
- Able to give informed consent (or authorize a family member) to be randomly assigned to receive the cyclo-ergometry program or conventional physiotherapy treatment.
- With or without connection to mechanical ventilation (via orotracheal tube or tracheostomy).
- Clinically stable (cardio-vascular, respiratory, neurological).
- With an inspired oxygen fraction less than or equal to 0.6 and requiring minimal ventilatory support (positive end-expiratory pressure less than or equal to 10 cm H2O).
Who cannot join
- Patients with pre-existing neuromuscular disease, spinal cord injury, cardiorespiratory arrest, stroke, patients with contraindications for mobility, pregnant women, advanced dementia or patients with life expectancy of less than 6 months or any situation that contraindicates the performance of cycloergometry.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Asociación Instituto Biogipuzkoa
Donostia / San Sebastian, Guipuzcoa, 20014
About this study
Official title: Ciclo-Ergometría en el Paciente Con Síndrome de Distrés Respiratorio Agudo
In March 2020 the World Health Organization declares the Coronavirus disease pandemic 2019. Intensive Care Units deal entirely with patients with pneumonia complicated by Acute Respiratory Distress Syndrome, requiring aggressive respiratory treatments with long periods of connection to mechanical ventilation, sedation and immobilization, contributing to the onset of acquired critical patient muscle weakness (IAPD). IUCD is a frequent complication in intensive care units, with an incidence of 11-67%¹. Of multifactorial cause, immobilization or "bed-rest", the use of corticosteroids and neuromuscular blocking agents have been described as factors directly related to this syndrome.
Several studies have shown that mobilization of the patient with acute respiratory distress syndrome, even with extracorporeal membrane oxygenation, is safe, feasible and beneficial for the patient. Bedside cyclo-ergometry has been associated with a reduction in the degree of sarcopenia, contributing to the recovery of the critically ill patient. Several studies document that bed cyclo-ergometry is safe and feasible in critically ill patients within the first week of admission to intensive care, but few clinical trials exist.
Read the detailed description
In March 2020 the World Health Organization declares the Coronavirus disease pandemic 2019. Intensive Care Units deal entirely with patients with pneumonia complicated by Acute Respiratory Distress Syndrome, requiring aggressive respiratory treatments with long periods of connection to mechanical ventilation, sedation and immobilization, contributing to the onset of acquired critical patient muscle weakness (IAPD).
IUCD is a frequent complication in intensive care units, with an incidence of 11-67%¹. Of multifactorial cause, immobilization or "bed-rest", the use of corticosteroids and neuromuscular blocking agents have been described as factors directly related to this syndrome. Each additional day of bed rest is associated with a 3 to 11% decrease in the strength of both peripheral and respiratory muscles, which translates into difficulty in weaning from mechanical ventilation, longer stay in the Intensive Care Unit and in the hospital in general, as well as an increase in morbidity and mortality. Similarly, in the first 24 hours after initiation of mechanical ventilation, diaphragmatic atrophy or dysfunction occurs, predisposing to prolonged mechanical ventilation. The need for ventilatory support for more than 48 hours has been associated with greater morbidity and mortality at hospital discharge, and survivors present greater disability and deterioration in their quality of life.
Several studies have shown that mobilization of the patient with acute respiratory distress syndrome, even with extracorporeal membrane oxygenation, is safe, feasible and beneficial for the patient. Most of the programs described in the literature include patients requiring extracorporeal membrane oxygenation, mainly in the pre-transplantation situation, and to a lesser extent patients with acute respiratory distress syndrome. They are characterized by the individual and progressive performance of functional activities of lesser to greater difficulty, starting with passive exercises of joint range, active and active-resisted exercises while the patients are in decubitus, progressing in some cases to sitting at the edge of the bed and less frequently to standing.
Bedside cyclo-ergometry has been associated with a reduction in the degree of sarcopenia, contributing to the recovery of the critically ill patient. Several studies document that bed cyclo-ergometry is safe and feasible in critically ill patients within the first week of admission to intensive care, but few clinical trials exist.
- Conditions
- Coronavirus
- Being tested
- Bed cyclo-ergonometry, Bed mobility activities (turning, pelvic elevation and sitting), standing, transfers and walking., Progressive upper and lower limb strength training
- Keywords
- Corticosteroids, Mobilization, Oxygenation, Cyclo-ergonometry, Acquired muscle weakness of the critically ill patient
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed cyclo-ergonometryOther
The MotoMed Letto 2 device will be used, with a progressive pattern, starting at 5 minutes and lasting up to 30 minutes. It will be performed once a day, during weekdays (Monday to Friday) until discharge from the intensive care unit, and at a modified Borg intensity of 2-3 (Light).
Bed mobility activities (turning, pelvic elevation and sitting), standing, transfers and walking.Other
Bed mobility activities (turning, pelvic elevation and sitting), standing, transfers and walking.
Progressive upper and lower limb strength trainingOther
Performing isometric exercises, strengthening with multi-resistance elastic bands or multi-weight dumbbells.
| Study group | Role | What they receive |
|---|---|---|
| Cyclo-ergonometry program group | Experimental | * Mobility activities in bed (turning, pelvic elevation and sitting), standing, transfers and walking.
* Progressive strength training of upper and lower limbs (2 days/week), by performing isometric exercises, strengthening with multi-resistance elastic bands or multi-weight dumbbells.
* Cycloergometry, using the MotoMed Letto 2 device, with a progressive pattern, starting with 5 minutes and lasting up to 30 minutes. It will be performed once a day, during working days (Monday to Friday) until discharge from the intensive care unit, and at a modified Borg intensity of 2-3 (Light). Receives: Other: Bed cyclo-ergonometry; Other: Bed mobility activities (turning, pelvic elevation and sitting), standing, transfers and walking.; Other: Progressive upper and lower limb strength training |
| Usual treatment group | Active comparator | * Mobility activities in bed (turning, pelvic elevation and sitting), standing, transfers and walking.
* Progressive strength training of upper and lower limbs (2 days/week), by performing isometric exercises, strengthening with multi-resistance elastic bands or multi-weight dumbbells. Receives: Other: Bed mobility activities (turning, pelvic elevation and sitting), standing, transfers and walking.; Other: Progressive upper and lower limb strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLINICAL ENDPOINT Age: Years completed at the time of inclusion in the study.
Continuous quantitative variable.
Measured: Until discharge from the intensive care unit
CLINICAL ENDPOINT Sex: Dichotomous qualitative variable
. Categories: Female/Male.
Measured: Until discharge from the intensive care unit
CLINICAL ENDPOINT Length of stay in the Intensive Care Unit: Number of days elapsed between admission and discharge from Intensive Care.
Continuous quantitative variable.
Measured: Until discharge from the intensive care unit
CLINICAL ENDPOINT Overall length of stay in hospital: Number of days between admission and discharge.
Continuous quantitative variable.
Measured: Until discharge from the intensive care unit
CLINICAL ENDPOINT Mechanical ventilation time:Number of days between intubation and successful weaning (defined as 48 hours of spontaneous breathing).
Continuous quantitative variable.
Measured: Until discharge from the intensive care unit
CLINICAL ENDPOINT Adverse events: Defined as the presence during or within 10 minutes of cyclo-ergometry of any of the following.
Discrete qualitative variable.
Loss of airway or venous/arterial lines. Increased vasoactive drug dosage: more than 5 mcg/min Increase in blood pressure: above 200 mmHg for more than 2 minutes. Drop in mean arterial blood pressure: below 60 mmHg for more than 2 minutes. Heart rate: below 50 bpm or above 140 bpm for more than 2 minutes. Drop in arterial oxygen saturation: below 88% for more than one minute requiring increasing the inspired oxygen fraction by more than 1% for more than 5 minutes.
Measured: Until discharge from the intensive care unit
FUNCTIONAL ENDPOINT Gait capacity: Measured by the 6-minute walk test at the time of discharge from hospital. A simple and inexpensive physical capacity test.
It reflects the level of physical activity in daily activities. It consists of walking as far as possible in 6 minutes, at a brisk pace without running, over a distance of about 30 metres. The main result is the distance covered and is recorded in metres. Arterial oxygen saturation and heart rate are monitored during the test. Available evidence suggests a minimum significant difference of 30 metres (25-33 metres) for adult patients with chronic respiratory disease.
Measured: Until discharge from the intensive care unit
FUNCTIONAL ENDPOINT Functional capacity: Measured at discharge from the Intensive Care Unit and at hospital discharge.
By performing the Short Physical Performance Battery (SPPB)³, a test consisting of 3 items: balance, gait speed and getting up and sitting in a chair 5 times. It assesses balance, gait ability and lower limb strength. The total score ranges from 0 (worst) to 12 points (best). The SSPB has been shown to be a valid instrument for detecting frailty and predicting disability, institutionalisation and mortality. A total score of less than 10 indicates frailty and a high risk of disability and falls. A 1-point change in score has clinical relevance.
Measured: Until discharge from the intensive care unit
FUNCTIONAL ENDPOINT Peripheral muscle strength on admission-discharge from ICU and hospital discharge.
Measurement of muscle strength using the Medical Research Council manual scale and using a dynamometer on admission and discharge from Intensive Care, as well as on discharge from hospital.
Measured: Until discharge from the intensive care unit
FUNCTIONAL ENDPOINT ICU MOBILITY SCALE (Spanish adaptation)
A valid and reliable scale that assesses the mobility of critically ill patients and helps to plan individualised activity programmes to prevent acquired muscle weakness in the critically ill patient.
Measured: Until discharge from the intensive care unit
FUNCTIONAL ENDPOINT Modified Borg Scale
Subjective assessment of perceived dyspnoea and fatigue during the training session.
Measured: Until discharge from the intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Apr 2021
- Primary completion18 Feb 2022
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled pilot clinical trial, with randomized assignment to two treatment groups, the cyclo-ergometry program group and the usual treatment group (parallel). The randomization will be carried out by blocks and will be kept in the Clinical Epidemiology Unit. When the physician has a patient available to enter the study, a call will be made to the Clinical Epidemiology Service where a randomization code and the group to which he/she has been assigned will be indicated.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogipuzkoa Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226428
- Sponsor's protocol ID
- MUGI-cu
- Acronym
- NPIDRA2021
- Status last verified
- Dec 2023
- First submitted
- 5 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ciclo-Ergometría en el Paciente Con Síndrome de Distrés Respiratorio Agudo
- ClinicalTrials.gov ID
- NCT06226428
- Acronym / sponsor ID
- NPIDRA2021 / MUGI-cu
- Conditions
- Coronavirus
- Keywords
- Corticosteroids, Mobilization, Oxygenation, Cyclo-ergonometry, Acquired muscle weakness of the critically ill patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Biogipuzkoa Health Research InstituteUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 26 Jan 2024 (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.
In March 2020 the World Health Organization declares the Coronavirus disease pandemic 2019. Intensive Care Units deal entirely with patients with pneumonia complicated by Acute Respiratory Distress Syndrome, requiring aggressive respiratory treatments with long periods of connection to mechanical ventilation, sedation and immobilization, contributing to the onset of acquired critical patient muscle weakness (IAPD). IUCD is a frequent complication in intensive care units, with an incidence of 11-67%¹. Of multifactorial cause, immobilization or "bed-rest", the use of corticosteroids and neuromuscular blocking agents have been described as factors directly related to this syndrome.
Several studies have shown that mobilization of the patient with acute respiratory distress syndrome, even with extracorporeal membrane oxygenation, is safe, feasible and beneficial for the patient. Bedside cyclo-ergometry has been associated with a reduction in the degree of sarcopenia, contributing to the recovery of the critically ill patient. Several studies document that bed cyclo-ergometry is safe and feasible in critically ill patients within the first week of admission to intensive care, but few clinical trials exist.
Detailed description
In March 2020 the World Health Organization declares the Coronavirus disease pandemic 2019. Intensive Care Units deal entirely with patients with pneumonia complicated by Acute Respiratory Distress Syndrome, requiring aggressive respiratory treatments with long periods of connection to mechanical ventilation, sedation and immobilization, contributing to the onset of acquired critical patient muscle weakness (IAPD).
IUCD is a frequent complication in intensive care units, with an incidence of 11-67%¹. Of multifactorial cause, immobilization or "bed-rest", the use of corticosteroids and neuromuscular blocking agents have been described as factors directly related to this syndrome. Each additional day of bed rest is associated with a 3 to 11% decrease in the strength of both peripheral and respiratory muscles, which translates into difficulty in weaning from mechanical ventilation, longer stay in the Intensive Care Unit and in the hospital in general, as well as an increase in morbidity and mortality. Similarly, in the first 24 hours after initiation of mechanical ventilation, diaphragmatic atrophy or dysfunction occurs, predisposing to prolonged mechanical ventilation. The need for ventilatory support for more than 48 hours has been associated with greater morbidity and mortality at hospital discharge, and survivors present greater disability and deterioration in their quality of life.
Several studies have shown that mobilization of the patient with acute respiratory distress syndrome, even with extracorporeal membrane oxygenation, is safe, feasible and beneficial for the patient. Most of the programs described in the literature include patients requiring extracorporeal membrane oxygenation, mainly in the pre-transplantation situation, and to a lesser extent patients with acute respiratory distress syndrome. They are characterized by the individual and progressive performance of functional activities of lesser to greater difficulty, starting with passive exercises of joint range, active and active-resisted exercises while the patients are in decubitus, progressing in some cases to sitting at the edge of the bed and less frequently to standing.
Bedside cyclo-ergometry has been associated with a reduction in the degree of sarcopenia, contributing to the recovery of the critically ill patient. Several studies document that bed cyclo-ergometry is safe and feasible in critically ill patients within the first week of admission to intensive care, but few clinical trials exist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled pilot clinical trial, with randomized assignment to two treatment groups, the cyclo-ergometry program group and the usual treatment group (parallel). The randomization will be carried out by blocks and will be kept in the Clinical Epidemiology Unit. When the physician has a patient available to enter the study, a call will be made to the Clinical Epidemiology Service where a randomization code and the group to which he/she has been assigned will be indicated.
| Arm | Type | Receives |
|---|---|---|
| Cyclo-ergonometry program group | Experimental | Other: Bed cyclo-ergonometry, Other: Bed mobility activities (turning, pelvic elevation and sitting), standing, transfers and walking., Other: Progressive upper and lower limb strength training* Mobility activities in bed (turning, pelvic elevation and sitting), standing, transfers and walking. * Progressive strength training of upper and lower limbs (2 days/week), by performing isometric exercises, strengthening with multi-resistance elastic bands or multi-weight dumbbells. * Cycloergometry, using the MotoMed Letto 2 device, with a progressive pattern, starting with 5 minutes and lasting up to 30 minutes. It will be performed once a day, during working days (Monday to Friday) until discharge from the intensive care unit, and at a modified Borg intensity of 2-3 (Light). |
| Usual treatment group | Active comparator | Other: Bed mobility activities (turning, pelvic elevation and sitting), standing, transfers and walking., Other: Progressive upper and lower limb strength training* Mobility activities in bed (turning, pelvic elevation and sitting), standing, transfers and walking. * Progressive strength training of upper and lower limbs (2 days/week), by performing isometric exercises, strengthening with multi-resistance elastic bands or multi-weight dumbbells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient 18 years of age or older
- Alert and cooperative (RASS agitation-sedation between -1 and +1).
- Able to give informed consent (or authorize a family member) to be randomly assigned to receive the cyclo-ergometry program or conventional physiotherapy treatment.
- With or without connection to mechanical ventilation (via orotracheal tube or tracheostomy).
- Clinically stable (cardio-vascular, respiratory, neurological).
Key exclusion criteria (1 listed)
- Patients with pre-existing neuromuscular disease, spinal cord injury, cardiorespiratory arrest, stroke, patients with contraindications for mobility, pregnant women, advanced dementia or patients with life expectancy of less than 6 months or any situation that contraindicates the performance of cycloergometry.
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 |
|---|---|---|
| Bed cyclo-ergonometryThe MotoMed Letto 2 device will be used, with a progressive pattern, starting at 5 minutes and lasting up to 30 minutes. It will be performed once a day, during weekdays (Monday to Friday) until discharge from the intensive care unit, and at a modified Borg intensity of 2-3 (Light). | Other | Cyclo-ergonometry program group |
| Bed mobility activities (turning, pelvic elevation and sitting), standing, transfers and walking.Bed mobility activities (turning, pelvic elevation and sitting), standing, transfers and walking. | Other | Cyclo-ergonometry program group, Usual treatment group |
| Progressive upper and lower limb strength trainingPerforming isometric exercises, strengthening with multi-resistance elastic bands or multi-weight dumbbells. | Other | Cyclo-ergonometry program group, Usual treatment group |
Primary outcome
CLINICAL ENDPOINT Age: Years completed at the time of inclusion in the study.
Time frame: Until discharge from the intensive care unit
Continuous quantitative variable.
CLINICAL ENDPOINT Sex: Dichotomous qualitative variable
Time frame: Until discharge from the intensive care unit
. Categories: Female/Male.
CLINICAL ENDPOINT Length of stay in the Intensive Care Unit: Number of days elapsed between admission and discharge from Intensive Care.
Time frame: Until discharge from the intensive care unit
Continuous quantitative variable.
CLINICAL ENDPOINT Overall length of stay in hospital: Number of days between admission and discharge.
Time frame: Until discharge from the intensive care unit
Continuous quantitative variable.
CLINICAL ENDPOINT Mechanical ventilation time:Number of days between intubation and successful weaning (defined as 48 hours of spontaneous breathing).
Time frame: Until discharge from the intensive care unit
Continuous quantitative variable.
CLINICAL ENDPOINT Adverse events: Defined as the presence during or within 10 minutes of cyclo-ergometry of any of the following.
Time frame: Until discharge from the intensive care unit
Discrete qualitative variable. Loss of airway or venous/arterial lines. Increased vasoactive drug dosage: more than 5 mcg/min Increase in blood pressure: above 200 mmHg for more than 2 minutes. Drop in mean arterial blood pressure: below 60 mmHg for more than 2 minutes. Heart rate: below 50 bpm or above 140 bpm for more than 2 minutes. Drop in arterial oxygen saturation: below 88% for more than one minute requiring increasing the inspired oxygen fraction by more than 1% for more than 5 minutes.
FUNCTIONAL ENDPOINT Gait capacity: Measured by the 6-minute walk test at the time of discharge from hospital. A simple and inexpensive physical capacity test.
Time frame: Until discharge from the intensive care unit
It reflects the level of physical activity in daily activities. It consists of walking as far as possible in 6 minutes, at a brisk pace without running, over a distance of about 30 metres. The main result is the distance covered and is recorded in metres. Arterial oxygen saturation and heart rate are monitored during the test. Available evidence suggests a minimum significant difference of 30 metres (25-33 metres) for adult patients with chronic respiratory disease.
FUNCTIONAL ENDPOINT Functional capacity: Measured at discharge from the Intensive Care Unit and at hospital discharge.
Time frame: Until discharge from the intensive care unit
By performing the Short Physical Performance Battery (SPPB)³, a test consisting of 3 items: balance, gait speed and getting up and sitting in a chair 5 times. It assesses balance, gait ability and lower limb strength. The total score ranges from 0 (worst) to 12 points (best). The SSPB has been shown to be a valid instrument for detecting frailty and predicting disability, institutionalisation and mortality. A total score of less than 10 indicates frailty and a high risk of disability and falls. A 1-point change in score has clinical relevance.
FUNCTIONAL ENDPOINT Peripheral muscle strength on admission-discharge from ICU and hospital discharge.
Time frame: Until discharge from the intensive care unit
Measurement of muscle strength using the Medical Research Council manual scale and using a dynamometer on admission and discharge from Intensive Care, as well as on discharge from hospital.
FUNCTIONAL ENDPOINT ICU MOBILITY SCALE (Spanish adaptation)
Time frame: Until discharge from the intensive care unit
A valid and reliable scale that assesses the mobility of critically ill patients and helps to plan individualised activity programmes to prevent acquired muscle weakness in the critically ill patient.
FUNCTIONAL ENDPOINT Modified Borg Scale
Time frame: Until discharge from the intensive care unit
Subjective assessment of perceived dyspnoea and fatigue during the training session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bed cyclo-ergonometry, Bed mobility activities (turning, pelvic elevation and sitting), standing, transfers and walking. and Progressive upper and lower limb strength training in people with Coronavirus, run by Biogipuzkoa Health Research Institute at 1 site in Spain.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLINICAL ENDPOINT Age: Years completed at the time of inclusion in the study. (time frame: Until discharge from the intensive care unit). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2024.