Exploration of Investigating ICU Mobilisation With Vasoactive Drugs

NCT03869541 | Completed Results

• 1 other identifier: 18SM4731
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness

Keywords

Critical Illness; Physical rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (approximately one day from enrolment)

• Number of Participants With Follow-up at 60 Days

  Patient participant follow-up rate at 60 days.

  60 days

Secondary Outcomes (26)

• Number of Participants Rating the 'Early Versus no Rehabilitation' Randomisation Scenario Was Acceptable

  Baseline (approximately one day from enrolment)

• Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable

  Baseline (approximately one day from enrolment)

• Number of Participants Rating the 'Protocolised Rehabilitation Versus Standard Care' Randomisation Scenario as Acceptable

  Baseline (approximately one day from enrolment)

• Number of Participants Where Participant Pre-morbid Comorbidities Measurement Was Not Completed.

  Baseline (approximately one day from enrolment)

• Number of Participants Where Participant Pre-morbid Frailty Measurements Were Not Completed.

  Baseline (approximately one day from enrolment)

Study Arms (3)

Intensive care patients

Adult intensive care patients receiving vasoactive drugs

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.

Interventions

Mobilization OTHER

Physical rehabilitation

Intensive care patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intensive care unit patients and clinicians.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Clinicians who work in the intensive care unit where a patient participant has been admitted.
• None.
• Clinician participants in the survey on the feasibility of the ICU physical rehabilitation adverse event tool:
• An ICU clinician at the research site.
• Has used the ICU physical rehabilitation adverse event tool as part of this research study.
• None.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Huw Woodbridge
• Organization: Imperial College London

h.woodbridge@imperial.ac.uk

+44 (0)20 7594 3192

Study Officials

• Anthony Gordon, Prof

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: March 11, 2019
• Study Start: December 14, 2018
• Primary Completion: August 9, 2019
• Study Completion: August 9, 2019
• Last Updated: November 11, 2021
• Results First Posted: September 10, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)