Critical IllnessNCT03869541
Exploration of Investigating ICU Mobilisation With Vasoactive Drugs
An observational study of Critical Illness, run by Imperial College London at 1 site in United Kingdom.
Trial summary
There is a need to know more about the safety of mobilizing intensive care unit (ICU) patients who are receiving vasoactive drugs that support the heart and blood pressure. But before this research can be done, several uncertainties need to be addressed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness
- What is being tested?
- Mobilization
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Dec 2018to 9 Aug 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Intensive care unit patients and clinicians.
Who may be able to join
- Patients admitted to the ICU who are receiving vasoactive drugs.
- Age greater than or equal to 18 years old.
- Expected to remain admitted to the ICU for at least 24 hours post-enrolment.
- Clinicians who work in the intensive care unit where a patient participant has been admitted.
- An ICU clinician at the research site.
- Has used the ICU physical rehabilitation adverse event tool as part of this research study.
Who cannot join
- Any patient who is expected to die imminently, as per clinical opinion.
- Any patient where mobilization is contraindicated by the nature of their existing injuries.
- Where it is clear from the medical records that participants are prisoners or offenders on probation.
- Patients with neuromuscular disease or acute brain injury or spinal cord injury.
- If the patient and/or their consultee is unable to speak English.
- Clinicians participating in a survey on hypothetical randomization of patient participants:
Show all 9Show fewer
- None.
- Clinician participants in the survey on the feasibility of the ICU physical rehabilitation adverse event tool:
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Safety of Mobilising Intensive Care Unit Patients Receiving Vasoactive Drugs: An Exploratory Observational Study
There is a need to know more about the safety of mobilizing intensive care unit (ICU) patients who are receiving vasoactive drugs that support the heart and blood pressure. But before this research can be done, several uncertainties need to be addressed.
To answer these uncertainties, the investigators will ask ICU patients receiving vasoactive drugs to take part in a study in three main stages. Firstly ICU patients will be asked whether they would be happy to take part in a future research trial on the safety of mobilizing patients who are receiving vasoactive drugs. Secondly, data will be collected about the current mobilization on vasoactive drugs that occurs. Finally, the investigators will try to follow up these patients 60 days after they start the study, to carry out some questionnaires and a walking test with the patients. These tests may be used in future research to measure the effect of mobilizing patients on vasoactive drugs.
Read the detailed description
The current evidence is insufficient to accurately guide clinicians to know when it is safe to start mobilizing intensive care unit (ICU) patients receiving vasoactive drugs. Before a randomized controlled trial can be designed, several uncertainties need to be addressed. This includes clarifying what standard care is, what potential recruitment rates would be and what the most suitable primary outcome measure is.
This study is an exploratory observational study which will aim to recruit up to 40 ICU patients receiving vasoactive drugs to further clarify standard care and to measure preliminary feasibility outcomes.
Upon enrolment, patients and clinicians will be surveyed about the hypothetical acceptability of recruitment into a future randomized controlled trial. Then any routine mobilization that occurs whilst the patient is receiving vasoactive drugs will be analyzed, for example, to describe how clinicians assessed safety for mobilization. Finally, patient participants will be followed up at day 60 to assess the feasibility of measuring candidate primary outcome measures.
- Conditions
- Critical Illness
- Being tested
- Mobilization
- Keywords
- Critical Illness, Physical rehabilitation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobilizationOther
Physical rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Intensive care patients | Adult intensive care patients receiving vasoactive drugs Receives: Other: Mobilization | |
| Intensive care unit clinicians | Clinicians for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial. | |
| ICU rehabilitation clinicians | Clinicians for participation in a survey on the feasibility of an ICU physical rehabilitation adverse event tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothetical Recruitment Rate for a Future Randomised Controlled Trial.
The number of patient participants who would hypothetically accept being randomised into a future trial on the safety of mobilising patients receiving vasoactive drugs.
Measured: Baseline (approximately one day from enrolment)
Number of Participants With Follow-up at 60 Days
Patient participant follow-up rate at 60 days.
Measured: 60 days
Secondary outcomes (26)
Number of Participants Rating the 'Early Versus no Rehabilitation' Randomisation Scenario Was Acceptable
Survey measuring participant acceptance of hypothetical randomisation scenarios: scenario 1: early versus no rehabilitation
Measured: Baseline (approximately one day from enrolment)
Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable
Survey measuring participant acceptance of hypothetical randomization scenarios: scenario 2: early rehabilitation versus standard care
Measured: Baseline (approximately one day from enrolment)
Number of Participants Rating the 'Protocolised Rehabilitation Versus Standard Care' Randomisation Scenario as Acceptable
Survey measuring participant acceptance of hypothetical randomization scenarios: scenario 3: protocolised rehabilitation versus standard care
Measured: Baseline (approximately one day from enrolment)
Number of Participants Where Participant Pre-morbid Comorbidities Measurement Was Not Completed.
Quantity of missing data resulting from measurement of participant pre-morbid co-morbidities.
Measured: Baseline (approximately one day from enrolment)
Number of Participants Where Participant Pre-morbid Frailty Measurements Were Not Completed.
Quantity of missing data resulting from measurement of participant pre-morbid frailty.
Measured: Baseline (approximately one day from enrolment)
Number of Participants Where Participant Pre-morbid Physical Function Measurement Was Not Completed.
Quantity of missing data resulting from measurement of participant pre-morbid physical function.
Measured: Baseline (approximately one day from enrolment)
Who Made the Final Decision Whether to Mobilize the Patient
Recorded whenever a physiotherapist reviews a patient participant for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was mobilized.
Measured: Through duration of ICU stay (average of 7 days).
The Reasons for the Decision When Patient Was Mobilized.
Recorded whenever a physiotherapist reviews a patient participant for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was mobilized.
Qualitative measure: reasons underwent content analysis, with the outcome being the themes summarizing the reasons.
Measured: Through duration of ICU stay (average of 7 days).
Who Made the Final Decision Whether to Not Mobilize the Patient
Recorded whenever a physiotherapist reviews a patient for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was not mobilized.
Measured: Through duration of intensive care stay (average 7 days)
The Reasons for the Decision When the Patient Was Not Mobilized.
Recorded whenever a physiotherapist reviews a patient for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was not mobilized.
Qualitative variable: reasons underwent qualitative analysis, with the output of a list of themes summarizing the reasons.
Measured: Through duration of intensive care stay (average 7 days)
The Reason Why a Mobilisation Treatment Was Stopped
Recorded if a mobilisation treatment on vasoactive drugs is routinely carried out.
Measured: Through duration of ICU stay (average of 7 days).
Number of Serious Adverse Events
Number of serious adverse events
Measured: Through whole of study, an estimated 6 months
Number of ICU Physical Rehabilitation Adverse Events
Recorded using ICU physical rehabilitation adverse event tool, both by treating clinician and by researcher case note review.
Measured: Through duration of ICU stay (average of 7 days).
Time Taken to Complete an ICU Physical Rehabilitation Adverse Event Tool.
Adverse event tool is completed if a mobilisation treatment on vasoactive drugs is routinely carried out.
Measured: Through duration of ICU stay (average of 7 days).
Loss of Information That Occurs When Completing ICU Physical Rehabilitation Adverse Event Tool.
Tool completed both by treating clinician and by researcher case note review. Number of mobilization treatment sessions on vasoactive drugs where adverse event tool is complete.
Measured: Through duration of ICU stay (average of 7 days).
Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey.
A survey measuring user opinion on whether an adverse event tool was for example understandable and an appropriate length using a scale with 'yes', 'no' or 'unsure' responses. Survey adapted from Hodgson, C., Needham, D., Haines, K., Bailey, M., Ward, A., Harrold, M., Young, P., Zanni, J., Buhr, H., Higgins, A., Presneill, J. \& Berney, S. 2014. Feasibility and inter-rater reliability of the ICU mobility scale. Heart Lung, 43.
Measured: Through second half of the study, an estimated 3 months
Time to First Mobilisation Treatment
Number of days to first rehabilitation treatment
Measured: Through duration of hospital stay (average of 22 days)
Time to First Being Able to Sit Out of Bed.
Regardless of the assistance required.
Measured: Through duration of hospital stay (average of 22 days)
Time to First Being Able to Stand.
Regardless of the assistance required.
Measured: Through duration of hospital stay (average of 22 days).
Time to First Being Able to Walk.
Regardless of assistance required.
Measured: Through duration of hospital stay (average of 22 days).
Intensive Care Unit Length of Stay.
Measured: From admission to ICU discharge (an average of 7 days)
Hospital Length of Stay
Measured: From admission to hospital discharge (average of 22 days)
Intensive Care Unit Mobility Scale Level at ICU Discharge.
Intensive care unit mobility scale records a patient's mobility level from 0 to 10, where 0 means no mobility and 10 means walking without assistance from people or a physical aid.
Measured: ICU discharge (an average of 7 days from ICU admission)
Number of Patient Participants Where All Candidate Primary Outcomes Are Completed.
Candidate primary outcomes: mortality, health-related quality of life, disability, physical functioning questionnaire and walking test.
Measured: 60 days.
The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome.
Candidate primary outcomes: mortality, health-related quality of life, disability, physical functioning questionnaire and walking test.
Measured: 60 days.
Data to Inform a Future Sample Size for a Future Randomized Controlled Trial.
Measures of central tendency and variability of data for candidate outcome measures to inform a sample size for future randomised controlled trial, e.g. physical functioning measured by the physical function domain of the RAND 36-Item Health Survey 1.0 Questionnaire (RAND SF-36 v1), scores range from 0-100, where a higher score means better physical functioning.
Measured: 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start14 Dec 2018
- Primary completion9 Aug 2019
- Study completion9 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Gordon, Prof, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869541
- Sponsor's protocol ID
- 18SM4731
- Status last verified
- Oct 2021
- First submitted
- 4 Jan 2019
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Safety of Mobilising Intensive Care Unit Patients Receiving Vasoactive Drugs: An Exploratory Observational Study
- ClinicalTrials.gov ID
- NCT03869541
- Acronym / sponsor ID
- 18SM4731
- Conditions
- Critical Illness
- Keywords
- Critical Illness, Physical rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Posted 10 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a need to know more about the safety of mobilizing intensive care unit (ICU) patients who are receiving vasoactive drugs that support the heart and blood pressure. But before this research can be done, several uncertainties need to be addressed.
To answer these uncertainties, the investigators will ask ICU patients receiving vasoactive drugs to take part in a study in three main stages. Firstly ICU patients will be asked whether they would be happy to take part in a future research trial on the safety of mobilizing patients who are receiving vasoactive drugs. Secondly, data will be collected about the current mobilization on vasoactive drugs that occurs. Finally, the investigators will try to follow up these patients 60 days after they start the study, to carry out some questionnaires and a walking test with the patients. These tests may be used in future research to measure the effect of mobilizing patients on vasoactive drugs.
Detailed description
The current evidence is insufficient to accurately guide clinicians to know when it is safe to start mobilizing intensive care unit (ICU) patients receiving vasoactive drugs. Before a randomized controlled trial can be designed, several uncertainties need to be addressed. This includes clarifying what standard care is, what potential recruitment rates would be and what the most suitable primary outcome measure is.
This study is an exploratory observational study which will aim to recruit up to 40 ICU patients receiving vasoactive drugs to further clarify standard care and to measure preliminary feasibility outcomes.
Upon enrolment, patients and clinicians will be surveyed about the hypothetical acceptability of recruitment into a future randomized controlled trial. Then any routine mobilization that occurs whilst the patient is receiving vasoactive drugs will be analyzed, for example, to describe how clinicians assessed safety for mobilization. Finally, patient participants will be followed up at day 60 to assess the feasibility of measuring candidate primary outcome measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensive care patients | – | Other: MobilizationAdult intensive care patients receiving vasoactive drugs |
| Intensive care unit clinicians | – | –Clinicians for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial. |
| ICU rehabilitation clinicians | – | –Clinicians for participation in a survey on the feasibility of an ICU physical rehabilitation adverse event tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care unit patients and clinicians.
Key inclusion criteria (6 listed)
- Patients admitted to the ICU who are receiving vasoactive drugs.
- Age greater than or equal to 18 years old.
- Expected to remain admitted to the ICU for at least 24 hours post-enrolment.
- Clinicians who work in the intensive care unit where a patient participant has been admitted.
- An ICU clinician at the research site.
Key exclusion criteria (9 listed)
- Any patient who is expected to die imminently, as per clinical opinion.
- Any patient where mobilization is contraindicated by the nature of their existing injuries.
- Where it is clear from the medical records that participants are prisoners or offenders on probation.
- Patients with neuromuscular disease or acute brain injury or spinal cord injury.
- If the patient and/or their consultee is unable to speak English.
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 |
|---|---|---|
| MobilizationPhysical rehabilitation | Other | Intensive care patients |
Primary outcome
Hypothetical Recruitment Rate for a Future Randomised Controlled Trial.
Time frame: Baseline (approximately one day from enrolment)
The number of patient participants who would hypothetically accept being randomised into a future trial on the safety of mobilising patients receiving vasoactive drugs.
Number of Participants With Follow-up at 60 Days
Time frame: 60 days
Patient participant follow-up rate at 60 days.
26 secondary outcomes
Number of Participants Rating the 'Early Versus no Rehabilitation' Randomisation Scenario Was Acceptable
Time frame: Baseline (approximately one day from enrolment)
Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable
Time frame: Baseline (approximately one day from enrolment)
Number of Participants Rating the 'Protocolised Rehabilitation Versus Standard Care' Randomisation Scenario as Acceptable
Time frame: Baseline (approximately one day from enrolment)
Number of Participants Where Participant Pre-morbid Comorbidities Measurement Was Not Completed.
Time frame: Baseline (approximately one day from enrolment)
Number of Participants Where Participant Pre-morbid Frailty Measurements Were Not Completed.
Time frame: Baseline (approximately one day from enrolment)
Number of Participants Where Participant Pre-morbid Physical Function Measurement Was Not Completed.
Time frame: Baseline (approximately one day from enrolment)
Who Made the Final Decision Whether to Mobilize the Patient
Time frame: Through duration of ICU stay (average of 7 days).
The Reasons for the Decision When Patient Was Mobilized.
Time frame: Through duration of ICU stay (average of 7 days).
Who Made the Final Decision Whether to Not Mobilize the Patient
Time frame: Through duration of intensive care stay (average 7 days)
The Reasons for the Decision When the Patient Was Not Mobilized.
Time frame: Through duration of intensive care stay (average 7 days)
The Reason Why a Mobilisation Treatment Was Stopped
Time frame: Through duration of ICU stay (average of 7 days).
Number of Serious Adverse Events
Time frame: Through whole of study, an estimated 6 months
Number of ICU Physical Rehabilitation Adverse Events
Time frame: Through duration of ICU stay (average of 7 days).
Time Taken to Complete an ICU Physical Rehabilitation Adverse Event Tool.
Time frame: Through duration of ICU stay (average of 7 days).
Loss of Information That Occurs When Completing ICU Physical Rehabilitation Adverse Event Tool.
Time frame: Through duration of ICU stay (average of 7 days).
Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey.
Time frame: Through second half of the study, an estimated 3 months
Time to First Mobilisation Treatment
Time frame: Through duration of hospital stay (average of 22 days)
Time to First Being Able to Sit Out of Bed.
Time frame: Through duration of hospital stay (average of 22 days)
Time to First Being Able to Stand.
Time frame: Through duration of hospital stay (average of 22 days).
Time to First Being Able to Walk.
Time frame: Through duration of hospital stay (average of 22 days).
Intensive Care Unit Length of Stay.
Time frame: From admission to ICU discharge (an average of 7 days)
Hospital Length of Stay
Time frame: From admission to hospital discharge (average of 22 days)
Intensive Care Unit Mobility Scale Level at ICU Discharge.
Time frame: ICU discharge (an average of 7 days from ICU admission)
Number of Patient Participants Where All Candidate Primary Outcomes Are Completed.
Time frame: 60 days.
The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome.
Time frame: 60 days.
Data to Inform a Future Sample Size for a Future Randomized Controlled Trial.
Time frame: 60 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Anthony Gordon, Prof principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Imperial College London at 1 site in United Kingdom.
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 9 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 11 Nov 2021. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 10 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hypothetical Recruitment Rate for a Future Randomised Controlled Trial. (time frame: Baseline (approximately one day from enrolment)). The study lists 2 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 11 Nov 2021.