Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS)

Cardiac Surgery Clinical Trial

— CORTIVAS-CS  

Official title:

Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS): a Prospective Randomized Double-blinded Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04301479
• Other study ID #: InCor - HCFMUSP
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 2020
• Est. completion date: March 2021

Study information

• Verified date: March 2020
• Source: Instituto do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Vasoplegia is an important determinant for adverse postoperative outcome and is observerd in 5% to 54% of patients undergoing cardiac surgery using cardiopulmonary bypass (CPB).

Postoperative vasoplegia is defined as a state with low systemic vascular resistance despite a normal or high cardiac output, and the need for vasopressor therapy.

Steroids attenuate the inflammatory response to cardiopulmonary bypass,but their effect on clinical outcomes is uncertain.

This is a double-blinded, randomized, clinical trial designed to determine the efficacy of low dose corticosteroid infusion in vasopressor free-days in vasoplegia after cardiac surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cardiac surgery with cardiopulmonary bypass

• Norephinerine treatment in ICU with dose great or equal than 0,1 mcg/kg/min to maintain or restore a MAP over 70 mmHg for at least 30 minutes within 24 hours after surgery

Exclusion Criteria:

• Preoperative vasopressor use (within 72 hours prior to surgery)

• Preoperative steroids use (within 7 days prior to surgery)

• Presence of ventricular assist device other than intraaortic ballon pump

• Transplant procedures

• Emergency procedures

• Aortic repairs

• Congenital procedures

• Endocarditis

• Bacterial or fungal infection in the preceding 30 days

• Active neoplasia

• Pregnancy

• Recent history of gastrointestinal bleeding

• Allergy or intolerance to steroids

• Participation in other study

Related Conditions & MeSH terms

• Cardiac Surgery
• Vasoplegia

Intervention

Drug:
• hydrocortisone sodium succinate
Steroid group will receive 200 mg of hydrocortisone diluted in 120 mL of saline at an infusion rate of 5mL/hr for 3 days or shock reversal
• Saline
Control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal

Locations

Country	Name	City	State
Brazil	Incor - Heart Institute - University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of mechanical ventilation	Duration in hours from the intraoperative intubation to postoperative extubation	30 days
Other	Post-operative length of stay	Post-operative LOS is the duration in days from the date of the end of surgery to the date of discharge from hospital.	30 days
Other	Mesenteric ischemia	We will compare the atrial fibrillation between groups within 30 days after randomization	30 days
Other	Acute respiratory distress syndrome	We will compare the incidence of acute respiratory distress syndrome between groups within 30 days after randomization	30 days
Other	Stroke	We will compare the incidence of stroke between groups within 30 days after randomization	30 days
Other	Hyperglycemia	Peak of capillary blood glucose glycemia up to 72 hours after the start the protocol solution	Up to 72 hours
Other	180 days mortallity	The number of deaths within 180 days of surgery	180 days
Primary	Vasopressors-free days	Days free of vasopressors up to day 30	30 days
Secondary	30 days mortallity	The number of deaths within 30 days of surgery	30 days
Secondary	ICU length of stay	Duration in days from the date of the ICU admission to the date of ICU discharge	30 days
Secondary	Infection complication	Rate of new infection or septic shock within 30 days after randomization	30 days
Secondary	Acute myocardial infarction	We will compare the incidence of acute myocardial infarction between groups within 30 days after randomization	30 days
Secondary	Atrial fibrillation	We will compare the incidence of atrial fibrillation between groups within 30 days after randomization	30 days