N/A
Completed N=100
Exploration of Investigating ICU Mobilisation With Vasoactive Drugs
Source: ClinicalTrials.gov NCT03869541 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Hypothetical Recruitment Rate for a Future Randomised Controlled Trial. — 30 Participants
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.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypothetical Recruitment Rate for a Future Randomised Controlled Trial. |
30 | — |
| PRIMARY Number of Participants With Follow-up at 60 Days |
40 | — |
| SECONDARY Number of Participants Rating the 'Early Versus no Rehabilitation' Randomisation Scenario Was Acceptable |
15; 11; 18; 6 | — |
| SECONDARY Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable |
25; 30; 28; 35 | — |
| SECONDARY Number of Participants Rating the 'Protocolised Rehabilitation Versus Standard Care' Randomisation Scenario as Acceptable |
24; 28; 27; 33 | — |
| SECONDARY Number of Participants Where Participant Pre-morbid Comorbidities Measurement Was Not Completed. |
8 | — |
| SECONDARY Number of Participants Where Participant Pre-morbid Frailty Measurements Were Not Completed. |
2 | — |
| SECONDARY Number of Participants Where Participant Pre-morbid Physical Function Measurement Was Not Completed. |
2 | — |
| SECONDARY Who Made the Final Decision Whether to Mobilize the Patient |
9; 7; 3; 1; 4; 1 | — |
| SECONDARY The Reasons for the Decision When Patient Was Mobilized. |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Who Made the Final Decision Whether to Not Mobilize the Patient |
20; 6; 3 | — |
| SECONDARY The Reasons for the Decision When the Patient Was Not Mobilized. |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY The Reason Why a Mobilisation Treatment Was Stopped |
10; 1; 2; 6; 2 | — |
| SECONDARY Number of Serious Adverse Events |
— | — |
| SECONDARY Number of ICU Physical Rehabilitation Adverse Events |
3; 6 | — |
| SECONDARY Time Taken to Complete an ICU Physical Rehabilitation Adverse Event Tool. |
2; 2; 1 | — |
| SECONDARY Loss of Information That Occurs When Completing ICU Physical Rehabilitation Adverse Event Tool. |
19; 41 | — |
| SECONDARY Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey. |
10; 9; 8; 10; 0; 0 | — |
| SECONDARY Time to First Mobilisation Treatment |
2 | — |
| SECONDARY Time to First Being Able to Sit Out of Bed. |
5 | — |
| SECONDARY Time to First Being Able to Stand. |
3 | — |
| SECONDARY Time to First Being Able to Walk. |
8 | — |
| SECONDARY Intensive Care Unit Length of Stay. |
7 | — |
| SECONDARY Hospital Length of Stay |
16 | — |
| SECONDARY Intensive Care Unit Mobility Scale Level at ICU Discharge. |
5 | — |
| SECONDARY Number of Patient Participants Where All Candidate Primary Outcomes Are Completed. |
6 | — |
| SECONDARY The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome. |
40; 16; 15; 15; 6 | — |
| SECONDARY Data to Inform a Future Sample Size for a Future Randomized Controlled Trial. |
20 | — |
Eligibility Criteria
Patient participants:
Inclusion Criteria
- 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.
Exclusion Criteria
- 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:
Inclusion criteria
- Clinicians who work in the intensive care unit where a patient participant has been admitted.
Exclusion criteria
- None.
Clinician participants in the survey on the feasibility of the ICU physical rehabilitation adverse event tool:
Inclusion criteria
- An ICU clinician at the research site.
- Has used the ICU physical rehabilitation adverse event tool as part of this research study.
Exclusion criteria
- None.
Data sourced from ClinicalTrials.gov (NCT03869541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.