CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients

Inflammatory Response Clinical Trial

— CORTERAS  

Official title:

CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220319
• Other study ID #: Z-2021070
• Status: Recruiting
• Phase: Phase 4
• Start date: February 3, 2022
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Ziekenhuis Oost-Limburg
• Contact: STEVEN THIESSEN
• Phone: 003289325294
• Email: steven.thiessen[@]zol.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Major surgery induces a systemic inflammatory response, which can influence the post-operative morbidity, such as coagulation disorders and post-operative muscle weakness, hampering early recovery after surgery.

Single administration of high dose corticosteroids is known to reduce this inflammatory response and could possibly improve the post-operative outcome.

The CORTERAS study will evaluate the effect of administration of corticosteroids, as compared to no corticosteroids, on postoperative muscle weakness and quality of recovery after surgery in elderly patients.

Description:

The number of elderly patients undergoing surgery is expected to increase in the coming years, due to the increase in life expectancy in the developing world. Compared to younger surgical patients, the older patients are at greater risk of mortality and morbidity after surgery.

Post-operative fatigue is an important complication after surgery. Not only is it reported by patients as one of the most distressing symptoms, it is also thought to be a significant contributor to delayed recovery after surgery. From a pathophysiological point of view, muscle weakness could be a major contributor to this post-operative fatigue.

Recent studies showed a profound reduction in muscle strength after surgery in elderly patients, which lasted for more than 3 months after surgery. This decrease in muscle strength might be induced by an excessive inflammatory response to surgery.

Glucocorticosteroids are capable of tampering an excessive inflammatory response to surgery and could improve the quality of recovery after surgery. However, a possible effect on post-operative muscle weakness hasn't been specifically investigated.

Therefore, the main objective of this prospective clinical trial is to evaluate the effect of corticosteroids on early post-operative outcome, focusing on muscle weakness, in elderly patients (≥60 years) undergoing surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 672
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Aged 60 years or older.

• Scheduled for one of the predefined surgical procedures:

• off-pump coronary bypass surgery

• on-pump coronary bypass surgery

• aortic and mitral valve replacement

• laparoscopic hemicolectomies

• thoracoscopic lung resections

• femoral popliteal and tibial bypass surgery and femoral profundoplasty

• laparoscopic radical prostatectomies

Exclusion Criteria:

• Lack of informed consent or inability to give informed consent.

• Severe postoperative nausea & vomiting (PONV), needing corticosteroids as PONV prophylaxis.

• Urgent, not elective surgery

• Hypersensitivity or known allergic reactions to methylprednisolone

• Preoperative systemic use of steroids:

• Including, but not limited to, the use of corticosteroids > 4 weeks before surgery of at least 4 mg methylprednisolone equivalents.

• Excluding inhalational and topical steroids

• Preexisting muscle disease o Including, but not limited to: Steinert's disease, amyotrophic lateral sclerosis (ALS), Duchenne dystrophy, amputation of dominant arm or hand.

Related Conditions & MeSH terms

• Inflammatory Response
• Muscle Weakness
• Weakness, Muscle

Intervention

Drug:
• Methylprednisolone
250 mg Methylprednisolone made up with 100 ml NaCl0,9% as an IV injection at the induction of anaesthesia but before surgery. If CPB is required an additional dose in 100 ml will be given.
• NaCl 0.9%
100 ml NaCl0,9% as an IV injection at the induction of anaesthesia but before surgery. If CPB is required an additional 100ml will be given.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative muscle weakness	decrease in muscle strength post-operatively, assessed by comparing the handgrip strength of the dominant hand, measured by the JAMAR dynamometer, on day 1 following surgery as compared to the preoperative value	Pre-operative and Post operative day 1
Secondary	Post operative muscle weakness	Decrease in muscle strength post-operatively, assessed by comparing the handgrip strength of the dominant hand, measured by the JAMAR dynamometer, on day 3 and 5 following surgery as compared to the preoperative value, if still in the hospital.	Pre-operative and Post operative day 1, 3 and 5
Secondary	Maximum inspiratory pressure as measure of respiratory muscle function	Maximum inspiratory pressure on day 1, 3 and 5, as compared to pre-operative value, if still in the hospital.	Pre-operative and Post operative day 1, 3 and 5
Secondary	Post operative fatigue	Assessed by the Chalder fatigue Questionnaire - 11 items, scores min 0 - max 33, higher score means worse outcome: post-operative day 1, 3, 5 and 28, as compared to preoperatively	Pre-operative and Post operative day 1, 3, 5 and 28
Secondary	Quality of recovery (QOR)	Assessed by the QOR-15 scale, scores min 0 - max 150, higher score means worse outcome, assessed on day 1, 3 and 5 as compared to preoperatively	Post operative day 1, 3 and 5
Secondary	Functioning at day 28	EuroQol five dimensions of health (EQ5D), score of 1-5 on each health dimension, higher score means worse outcome + visual analogue scale from 0-100 questionning todays health, lower score means worse outcome. EQ5D is assessed on day 28, as compared to pre-operatively values	Pre-operative and Post operative day 28
Secondary	Coagulation disorder	biochemical markers of coagulation postoperatively as compared to preoperatively	postoperatively first 24 hours
Secondary	Sleeping pattern	Assessed by the Consensus Sleep Diary (CSD) in a subset of study population	10 consecutive nights, starting 3 days before surgery
Secondary	Sleep quality	Assessed by the Pittsburgh Sleep Quality Index (PSQI) in a subet of study population, score range between 0 and 21, higher scores indicate worse sleep quality	3 days before and 10 days after surgery
Secondary	Sleep chronotype	Assessed by the Munich Chronotype Questionnaire (MCTQ) is a subset of study population	3 days before surgery
Secondary	Sleeping EEG pattern	Assessed by EEG recording in a subset of study population	first postoperative night