Clinical trial NCT03869541: Exploration of Investigating ICU Mobilisation With Vasoactive Drugs
Official title: Investigating the Safety of Mobilising Intensive Care Unit Patients Receiving Vasoactive Drugs: An Exploratory Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: Critical Illness
Physical rehabilitation
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care unit patients and clinicians.

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.

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.

Primary outcomes:
measure: Hypothetical Recruitment Rate for a Future Randomised Controlled Trial.
timeFrame: Baseline (approximately one day from enrolment)
measure: Number of Participants With Follow-up at 60 Days
timeFrame: 60 days
Secondary outcomes:
measure: Number of Participants Rating the 'Early Versus no Rehabilitation' Randomisation Scenario Was Acceptable
timeFrame: Baseline (approximately one day from enrolment)
measure: Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable
timeFrame: Baseline (approximately one day from enrolment)
measure: Number of Participants Rating the 'Protocolised Rehabilitation Versus Standard Care' Randomisation Scenario as Acceptable
timeFrame: Baseline (approximately one day from enrolment)
measure: Number of Participants Where Participant Pre-morbid Comorbidities Measurement Was Not Completed.
timeFrame: Baseline (approximately one day from enrolment)
measure: Number of Participants Where Participant Pre-morbid Frailty Measurements Were Not Completed.
timeFrame: Baseline (approximately one day from enrolment)
measure: Number of Participants Where Participant Pre-morbid Physical Function Measurement Was Not Completed.
timeFrame: Baseline (approximately one day from enrolment)
measure: Who Made the Final Decision Whether to Mobilize the Patient
timeFrame: Through duration of ICU stay (average of 7 days).
measure: The Reasons for the Decision When Patient Was Mobilized.
timeFrame: Through duration of ICU stay (average of 7 days).
measure: Who Made the Final Decision Whether to Not Mobilize the Patient
timeFrame: Through duration of intensive care stay (average 7 days)
measure: The Reasons for the Decision When the Patient Was Not Mobilized.
timeFrame: Through duration of intensive care stay (average 7 days)
measure: The Reason Why a Mobilisation Treatment Was Stopped
timeFrame: Through duration of ICU stay (average of 7 days).
measure: Number of Serious Adverse Events
timeFrame: Through whole of study, an estimated 6 months
measure: Number of ICU Physical Rehabilitation Adverse Events
timeFrame: Through duration of ICU stay (average of 7 days).
measure: Time Taken to Complete an ICU Physical Rehabilitation Adverse Event Tool.
timeFrame: Through duration of ICU stay (average of 7 days).
measure: Loss of Information That Occurs When Completing ICU Physical Rehabilitation Adverse Event Tool.
timeFrame: Through duration of ICU stay (average of 7 days).
measure: Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey.
timeFrame: Through second half of the study, an estimated 3 months
measure: Time to First Mobilisation Treatment
timeFrame: Through duration of hospital stay (average of 22 days)
measure: Time to First Being Able to Sit Out of Bed.
timeFrame: Through duration of hospital stay (average of 22 days)
measure: Time to First Being Able to Stand.
timeFrame: Through duration of hospital stay (average of 22 days).
measure: Time to First Being Able to Walk.
timeFrame: Through duration of hospital stay (average of 22 days).
measure: Intensive Care Unit Length of Stay.
timeFrame: From admission to ICU discharge (an average of 7 days)
measure: Hospital Length of Stay
timeFrame: From admission to hospital discharge (average of 22 days)
measure: Intensive Care Unit Mobility Scale Level at ICU Discharge.
timeFrame: ICU discharge (an average of 7 days from ICU admission)
measure: Number of Patient Participants Where All Candidate Primary Outcomes Are Completed.
timeFrame: 60 days.
measure: The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome.
timeFrame: 60 days.
measure: Data to Inform a Future Sample Size for a Future Randomized Controlled Trial.
timeFrame: 60 days.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Anthony Gordon, Prof
role: PRINCIPAL_INVESTIGATOR
References: