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

Sponsor
Imperial College London (Other)
Overall Status
Completed
CT.gov ID
NCT03354767
Collaborator
(none)
40
21

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Nov 1, 2013
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Change in Rectus Femoris muscle cross-sectional area (%) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Imperial College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT03354767
Other Study ID Numbers:
  • ImperialC
First Posted:
Nov 28, 2017
Last Update Posted:
Nov 28, 2017
Last Verified:
Apr 1, 2013
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 28, 2017