Post-operative Corticosteroid Treatment After Mitral Valve Surgery

NCT03682393 | Withdrawn Phase 2

• 1 other identifier: KUH5101126
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to intestigate whether three days intravenous corticosteroid management prevent atrial fibrillations in adults after mitral valve surgery. Prospective double-blinded randmized international multicenter study.

Conditions

Atrial Fibrillation

Keywords

postoperative; atrial fibrillation; post cardiac surgery; corticosteroid

Outcome Measures

Primary Outcomes (1)

• atrial fibrillation

  Atrial fibrillation onset in the timeframe of three postoperative days after mitral valve surgery.

  three days after mitral valve surgery

Study Arms (2)

Hydrocortisone

EXPERIMENTAL

100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset

Drug: Hydrocortisone

Placebos

PLACEBO COMPARATOR

100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset

Drug: Placebos

Interventions

Hydrocortisone DRUG

100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset

Also known as: corticosteroid

Hydrocortisone

Placebos DRUG

100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset

Also known as: placebo, saline

Placebos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• open mitral valve surgery
• patients agrees to participate in the study
• adult (minimum 18 years of age)

You may not qualify if:

• atrial fibrillation onset before first postoperative morning
• prolonged intensive care unit stay (patient needs to stay in intensive care unit after first postoperative day)
• patient is underaged, does not want to participate or can not make the decision by himself or herself because of ie memory disability
• diabetes mellitus requiring insulin treatment and with recent hypo- or hyperglycemias which required hospital treatment
• systemic mucous infections
• known allergy or oversensitivity to hydrocortisone
• Cushing syndrome
• history of psychosis
• history of ulcus or active ulcus
• chronic atrial fibrillation or atrial flutter
• corticosteroid or immunosuppressive treatment in use for any reason
• active tuberculosis infection
• severe renal impairment (serum creatinine 200 umol/l or over)
• history of deep or superficial venous trombosis
• Herpes simplex -ceratitis

Sponsors & Collaborators

• Kuopio University Hospital: lead

Study Sites (1)

Kuopio University Hospital

Kuopio, 70029, Finland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Hydrocortisone; Adrenal Cortex Hormones; Sodium Chloride

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jari Halonen, MD, PhD

  general surgery attending, clinical teacher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study is double blinded, neither the patients or investigators or nurses managing the drugs do not know whether the patient receives placebo (isotonic saline) or active drug (corticosteroid). In case of emergency the codes can be cracked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: half of the recruited patients will receive intravenous corticosteroid and the other half will receive intravenous isotonic saline as placebo

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 24, 2018
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)