Clinical Trials Logo

Clinical Trial Summary

To observe and identify determinants of recovery from intensive care unit-acquired weakness (ICUAW) following a severe cardiorespiratory failure requiring extra-corporeal membrane oxygenation (ECMO). Additionally, to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after critical illness. CLEVERER is a clinical observational pilot study.

Clinical Trial Description

To identify determinants of recovery from ICUAW and to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after critical illness. This phenomenon has become more evident over recent years and still requires extensive research.

ICUAW is an umbrella term for more specifically polyneuropathy and myopathy. Recent research has found that 50% of patients undergoing elective cardiac surgery lose significant muscle mass (9.6% in the wasters group) within the first seven days. These patients are receiving relatively uncomplicated surgery yet still suffering from muscle breakdown, which cannot be described by inactivity alone. The investigators wish to observe ICUAW in a real-life context, however, where cases are always severe. ICUAW can lead to a significant increase in mortality and morbidity. Risk factors for ICUAW include neuromuscular blocking agents, hyperglycaemia, inactivity and sepsis. The correlation between a patient group with severe cardiorespiratory failure and patient-centred outcomes during recovery such as functional ability and health-related quality of life (HRQoL) has been little studied.

Severe cardiac and respiratory failure can both be supported by a mechanical cardio-respiratory support (MCS) including extra-corporeal membrane oxygenation (ECMO); therefore referral for this intervention can be used as a marker of the severest form of cardiorespiratory failure. Both conditions are associated with a high incidence of collateral multi-organ dysfunction and mortality; as well as long-term morbidity, loss of independence and reduced quality of life. Patients with acute cardiac and respiratory failure referred to St Bartholomew's hospital for consideration of MCS will be recruited by advice/guidance from a personal and professional consultee.

Rectus femoris cross-sectional area (RFcsa) will be measured by ultrasound during the first week of admission and at pre-determined time points. The RFcsa will be correlated with indices of muscle strength, physical function and HRQoL. The investigators will also take blood and urine samples on arrival and at pre-defined intervals during the patients' admission for circulating and respiratory markers of sepsis, oxidative stress and organ injury. A muscle biopsy will be taken from the operation field if the patient is centrally cannulated when initiating ECMO.

The primary Objective is to identify determinants of recovery from ICUAW and to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after severe cardiorespiratory failure. Specifically, to observe the cross-sectional area of the Rectus Femoris (RFcsa) and correlate this with muscle strength and HRQoL during recovery. RFcsa, hand-held dynamometry, knee straightening dynamometry, Free Fat Mass Index, standing and lying vital capacity, MRC-SS sum score and short physical performance battery (SPPB) will be observed. Also, HRQoL will be measured using the reintegration to normal living index (RNLI), hospital and anxiety depression score (HADS)and the EQ-5D-5L (EuroQol research foundation). Additionally, we have composed a 10 item questionnaire to assess pre-morbid functional status. The primary endpoint will be once all these data are gathered and analysed.

The secondary aim is to understand the molecular and genomic profile of blood samples and the histology of the muscle biopsies. The objective will be supported with additional data from urine analysis (albumin-creatinine ratio) and vascular endothelial cells. The secondary endpoint will be once these data are collected and analysed. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03753412
Study type Observational
Source Barts & The London NHS Trust
Contact Mark Griffiths, PhD FRCP
Phone 07875999126
Status Recruiting
Start date April 9, 2019
Completion date August 1, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT03472768 - The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
Not yet recruiting NCT03662438 - HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT) N/A
Not yet recruiting NCT02542423 - Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. N/A
Completed NCT02265198 - Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome N/A
Recruiting NCT01941524 - Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations Phase 4
Completed NCT01885442 - TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients N/A
Completed NCT02105298 - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study) N/A
Completed NCT02814994 - Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients N/A
Completed NCT01659268 - Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins N/A
Completed NCT01204281 - Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients Phase 4
Terminated NCT01333059 - Cycling of Sedative Infusions in Critically Ill Pediatric Patients N/A
Completed NCT01249794 - Non Invasive Ventilation After Cardiac Surgery N/A
Recruiting NCT00526981 - Prone Position for Non-intubated Patients With Acute Respiratory Failure N/A
Completed NCT00678912 - Weaning Children From Mechanical Ventilation:Computer-driven System Versus Usual Care Phase 3
Enrolling by invitation NCT03440593 - Indirect Calorimetry Usage and Effect in Ventilator-free Days and Muscle Thickness in Septic Ventilated Patients N/A
Recruiting NCT03201263 - Sigh in Acute Hypoxemic Respiratory Failure N/A
Completed NCT03452046 - Inferior Vena Cava Indexes in Positive Pressure Supports
Recruiting NCT03728491 - Education and Training Competences in Thoracic Ultrasound N/A
Recruiting NCT03546699 - Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS
Not yet recruiting NCT03696563 - FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS N/A