Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Role of Ischaemia-reperfusion Injury in the Pathogenesis of Muscle Wasting After Thoracic Aortic Surgery (RIMMAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03354767
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
Single-centre observational study over one year investigating the mechanisms of muscle homeostasis in patients with acute skeletal muscle atrophy following major aortic surgery

Condition or disease Intervention/treatment
Muscular Diseases Procedure: Aortic and aortic valve surgery

Detailed Description:

Some patients who are critically ill develop a syndrome of muscle weakness called Intensive Care Unit Acquired Paresis. This syndrome involves the development of severe muscle wasting and weakness and affects all skeletal muscles including the muscles which help one breathe. Muscle wasting and weakness whilst critically ill cause prolongation of mechanical ventilation, longer stays on the ICU, reduced mobility and prolonged rehabilitation in survivors. It has also been shown to increase the risk of death on ICU, due to an inability to wean patients from mechanical ventilation. Most patients recover; however in some, the effects last for many years and patients may not recover fully.

Although there is some understanding of why this syndrome develops, the molecular processes underlying the muscle wasting are not well understood. From the current scientific evidence, the investigators have identified a group or family of proteins believed to be important in the development of this condition, the activity of which are regulated by disease processes thought to lead to Intensive Care Unit Acquired Paresis (e.g. infection, inflammation, oxidative stress, immobility).

This research aims to investigate the role of these proteins in human tissue from patients who are at risk of Intensive Care Unit Acquired paresis. Even patients who do not go on to develop the full syndrome, in the early stages of ICU care, show some signs of muscle changes and loss of strength.

Layout table for study information
Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study Into the Effect on Muscle Wasting and Multiple Organ Function of Ischaemia-reperfusion Injury After Major Aortic Surgery
Study Start Date : November 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : August 2015

Group/Cohort Intervention/treatment
Wasting patients
Patients with >10% loss of skeletal muscle one week after major aortic surgery
Procedure: Aortic and aortic valve surgery
Non-wasting patients
Patients with <10% loss of skeletal muscle one week after major aortic surgery
Procedure: Aortic and aortic valve surgery



Primary Outcome Measures :
  1. Change in Rectus Femoris muscle cross-sectional area (%) [ Time Frame: 7 days ]
    Percentage change in cross sectional area of Rectus Femoris muscle (cm2) in the first post-operative week, from pre-operative measurement (measured the day before surgery), repeated on day 7 post-operatively


Biospecimen Retention:   Samples Without DNA
  1. Plasma
  2. Serum
  3. Whole blood
  4. Skeletal muscle


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients undergoing major aortic or aortic valve surgery requiring cardiopulmonary bypass and aortic cross-clamping
Criteria

Inclusion Criteria:

  • All adult (>18) patients undergoing major aortic or aortic valve surgery

Exclusion Criteria:

  • Pre-existing cause for neuromuscular weakness or severe wasting (such as previous stroke, neuromuscular disease or malignancy)
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03354767    
Other Study ID Numbers: ImperialC
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: April 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscular Diseases
Muscular Atrophy
Reperfusion Injury
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Signs and Symptoms
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Musculoskeletal Diseases
Neuromuscular Diseases