A Phase 3 interventional study of hydrocortisone sodium succinate and Saline in Vasoplegia and Cardiac Surgery, sponsored by Instituto do Coracao. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by Instituto do Coracao · Phase 3, Interventional, and Treatment
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.
48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.
This study's planned enrollment of 140 is above the median of 110 across 27 interventional studies indexed under Vasoplegia.
Browse Vasoplegia studies →Instituto do Coracao is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients assigned for 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, defined by systolic arterial pressure \> 90 mmHg for 12 hours after vasopressor weaning without fluid expansion.
Drug: hydrocortisone sodium succinate
Patients assigned for control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal, defined by systolic arterial pressure \> 90 mmHg for 12 hours after vasopressor weaning without fluid expansion.
Drug: Saline
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
Control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal
Vasopressors-free days
Days free of vasopressors up to day 30
Time frame: 30 days
30 days mortallity
The number of deaths within 30 days of surgery
Time frame: 30 days
ICU length of stay
Duration in days from the date of the ICU admission to the date of ICU discharge
Time frame: 30 days
Infection complication
Rate of new infection or septic shock within 30 days after randomization
Time frame: 30 days
Acute myocardial infarction
We will compare the incidence of acute myocardial infarction between groups within 30 days after randomization
Time frame: 30 days
Atrial fibrillation
We will compare the incidence of atrial fibrillation between groups within 30 days after randomization
Time frame: 30 days
Duration of mechanical ventilation
Duration in hours from the intraoperative intubation to postoperative extubation
Time frame: 30 days
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.
Time frame: 30 days
Mesenteric ischemia
We will compare the atrial fibrillation between groups within 30 days after randomization
Time frame: 30 days
Acute respiratory distress syndrome
We will compare the incidence of acute respiratory distress syndrome between groups within 30 days after randomization
Time frame: 30 days
Stroke
We will compare the incidence of stroke between groups within 30 days after randomization
Time frame: 30 days
Hyperglycemia
Peak of capillary blood glucose glycemia up to 72 hours after the start the protocol solution
Time frame: Up to 72 hours
180 days mortallity
The number of deaths within 180 days of surgery
Time frame: 180 days
Start is estimated for Mar 2020; primary completion for Mar 2021, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Hydrocortisone hemisuccinate
Instituto do Coracao