Exploration of Investigating ICU Mobilisation With Vasoactive Drugs

NCT ID: NCT03869541

Last Updated: 2021-11-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-14
• Study Completion Date: 2019-08-09

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.

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

Keywords

Critical Illness; Physical rehabilitation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intensive care patients

Adult intensive care patients receiving vasoactive drugs

Mobilization

Intervention Type: OTHER

Physical rehabilitation

Intensive care unit clinicians

Clinicians for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.

No interventions assigned to this group

ICU rehabilitation clinicians

Clinicians for participation in a survey on the feasibility of an ICU physical rehabilitation adverse event tool.

No interventions assigned to this group

Interventions

Mobilization

Physical rehabilitation

Intervention Type: OTHER

Eligibility Criteria

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.

• 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.

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:

• None.

Clinician participants in the survey on the feasibility of the ICU physical rehabilitation adverse event tool:

• None.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Gordon, Prof

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Imperial College Healthcare NHS Trust

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18SM4731

Identifier Type: -

Identifier Source: org_study_id