Exploration of Investigating ICU Mobilisation With Vasoactive Drugs

Status Completed

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Critical Illness

Clinical Trial Details

NCT number	NCT03869541
Study type	Observational
Source	Imperial College London
Contact
Status	Completed
Phase
Start date	December 14, 2018
Completion date	August 9, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.