The role of hydrocortisone pre-treatment in decreasing side effects of protamine sulfate administration during cardiac surgery: a randomised controlled trial
Abstract
Background
One of the challenges during cardiac surgery is to keep patients fully anticoagulated during the cardiopulmonary bypass time and reversing anticoagulation at the end of surgery. For that purpose, heparin and its approved reversal agent, protamine sulfate have been widely used. Protamine sulfate is known to have side effects which can be life-threatening including anaphylaxis, which can affect the outcome for the entire procedure. In this randomized control study, we investigated the effect of using hydrocortisone pre-treatment to decrease the side effects of protamine sulfate. The primary hypothesis was that patients pre-treated with hydrocortisone would have less variation in intraoperative hemodynamic parameters.
Methods
In this parallel group, randomized, controlled trial with 1:1 allocation ratio, we compared the hemodynamic parameters in patients who had cardiac surgery using cardiopulmonary bypass from July 2019 to April 2020. The study allocated patients into two groups. The intervention group included patients who received hydrocortisone before giving protamine sulfate and the control group received normal saline.
Results
No clinically significant differences were reported between basic characteristics of the two groups. In the intervention group, mean reduction of systolic blood pressure was 6.2 mmHg (±2.6) while it was 14.5 mmHg (± 3.7) for control group, P<0.01, Cohen’s effect size (d) = 2.61 (95% CI: 2.23-2.99). Mean reduction in diastolic blood pressure where 5.7 mmHg (±3.5) in the intervention group and 11.2 mmHg (±3.1) in the control group, P<0.01, d= 1.64 (95% CI: 1.32-1.97). Means for mean arterial blood pressure were decreased by 5.9 mmHg (± 2.9) in the intervention group and 12.3 mmHg (± 2.9) in the control group, respectively, P<0.01, d=2.18 (95% CI: 1.83-2.53). Heart rate increased in the control group, mean increase being 15.4 bpm (± 5.5), more than in the intervention group 10.7 bpm (± 3.2), P<0.01, d=1.05 (95% CI: 0.75-1.34). No side effects were reported during the intraoperative procedure.
Conclusion
Hydrocortisone can be used effectively as a prophylactic agent to minimize intraoperative hemodynamic deterioration resulting from protamine sulfate in adult cardiac surgery patients.