This study is a parallel group, single blind, randomized controlled trial. Patients with pulmonary hypertension who met the inclusion criteria and planned to undergo elective cardiac surgery under cardiopulmonary bypass from July 1, 2022 to December 1, 2024 in the Department of cardiac surgery of the First Affiliated Hospital of Shandong First Medical University were selected. After removing the aortic blocking forceps, the experimental group immediately injected the test drug (pituitrin 0.04u/ (kg · h)) intravenously, The control group was immediately injected with the corresponding dose of normal saline by intravenous pump. The main outcome was the composite endpoint of all-cause mortality 30 days after operation or common complications after cardiac surgery (stroke, requiring mechanical ventilation for more than 48 hours, deep sternal wound infection, cardiac reoperation, extracorporeal membrane oxygenation, atrial fibrillation or acute renal injury).
Cardiac surgery is the most important treatment for serious coronary heart disease, valvular heart disease, congenital heart disease and other heart diseases. Its postoperative mortality and serious complications have also been widely concerned, especially in patients with pulmonary hypertension. The persistent pulmonary hypertension and systemic vascular paralysis during the perioperative period are the main causes of early postoperative death and serious complications such as organ failure.Catecholamine vasoactive drugs commonly used in cardiac surgery may aggravate the condition of pulmonary hypertension, while the use of drugs to reduce pulmonary hypertension, such as nitric oxide, prostaglandins and phosphodiesterase inhibitors, may worsen the state of systemic vascular paralysis. Vasopressin and oxytocin are two effective components in pituitrin, and vasopressin is the main component that exerts strong vasoconstrictive effect.Vasopressin binds to receptors distributed in vascular smooth muscle, pituitary and kidney, and exerts its effects by regulating adenosine triphosphate sensitive K+ channel function, nitric oxide production and enhancing vascular response to catecholamine.In addition, oxytocin can also bind to the receptors distributed in the heart and vascular endothelium, and play a role by releasing atrial natriuretic peptide and nitric oxide.Therefore, pituitrin can not only constrict systemic circulation vessels and increase systemic circulation pressure, reduce pulmonary artery pressure and pulmonary vascular resistance, but also protect the heart and kidney. Therefore, this study intends to explore whether pituitrin has an impact on the prognosis of patients with pulmonary hypertension after cardiac surgery, so as to provide reference for its clinical application.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
The specification of posterior pituitary injection is 1ml/6U, diluted with normal saline to 0.5u/ml, and injected by intravenous pump at the rate of 0.04u/ (kg · h).
Intravenous infusion of normal saline at the same dose and speed
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, China
a composite endpoint of mortality or severe postoperative complications
severe complications after cardiac surgery, including stroke, requirement of mechanical ventilation for longer than 48h, deep sternal wound infection, reoperation, or acute renal failure
Time frame: Within 30 days after cardiac surgery
incidence of postoperative infection
The patient appears infection after surgery.
Time frame: Within 30 days after cardiac surgery
septic shock
Septic shock was defined as the septic syndrome with shock caused by microorganisms and their toxins.
Time frame: Within 30 days after cardiac surgery
duration of mechanical ventilation
Total duration of mechanical ventilation during or after surgery.
Time frame: Time from the beginning of mechanical ventilation to the end of mechanical ventilation up to 30 days after cardiac surgery.
postoperative pulmonary complications
This is a composite endpoint indicator, includs atelectasis, pleural effusion, diaphragmatic dysfunction, prolonged mechanical ventilation, pneumonia, pneumothorax, acute respiratory distress syndrome, etc.The occurrence of any of the above pulmonary complications is considered as a positive outcome.
Time frame: Within 30 days after cardiac surgery
time to achieve hemodynamic stability
From hemodynamic change to hemodynamic stability.
Time frame: Within 30 days after cardiac surgery
use of dobutamine or other vasoactive drugs
The patients use dobutamine or other vasoactive drugs.
Time frame: Within 30 days after cardiac surgery
incidence of digital ischemia
Digital ischemia is a symptom caused by insufficient blood supply to the fingers.
Time frame: Within 30 days after cardiac surgery
acute mesenteric ischemia
Acute mesenteric ischemia includes arterial and venous thrombosis, thrombosis, and vasoconstriction secondary to low blood flow. Arterial lesions mainly included superior mesenteric artery embolism, superior mesenteric artery thrombosis and non occlusive mesenteric ischemia. The main venous lesions were mesenteric venous thrombosis.
Time frame: Within 30 days after cardiac surgery
gastrointestinal complications
Including dyspepsia, abdominal distension, constipation, postoperative stress ulcer, gastrointestinal bleeding, etc.
Time frame: Within 30 days after cardiac surgery
incidence of acute myocardial infarction
Acute myocardial infarction is myocardial necrosis caused by acute and persistent ischemia and hypoxia of coronary artery.
Time frame: Within 30 days after cardiac surgery
new onset tachyarrhythmia
Tachyarrhythmia includes premature beat, tachycardia, atrial fibrillation and ventricular fibrillation, etc.
Time frame: Within 30 days after cardiac surgery
water poisoning
Water poisoning refers to that when the total amount of water ingested by the body greatly exceeds the amount of water discharged, so that water is retained in the body, resulting in the decrease of plasma osmotic pressure and the increase of circulating blood volume.
Time frame: Within 30 days after cardiac surgery
vasodilative shock
Vasodilative shock is caused by vasodilation, increased vascular bed volume and relatively insufficient intravascular blood volume, including septic shock, anaphylactic shock and neurogenic shock.
Time frame: Within 30 days after cardiac surgery
incidence of pulmonary embolism
Pulmonary embolismwas defined as clinical pathophysiological syndrome of pulmonary circulatory dysfunction caused by pulmonary artery and its branches blocked by various emboli falling off of systemic circulation.
Time frame: Within 30 days after cardiac surgery
low cardiac output syndrome
Low cardiac output syndrome refers to the complex pathophysiological changes of insufficient perfusion of multiple organs and tissue hypoxia due to the decrease of cardiac output.
Time frame: Within 30 days after cardiac surgery
acute respiratory distress syndrome
Acute respiratory distress syndrome (ARDS) is a clinical syndrome characterized by refractory hypoxemia, which is caused by intrapulmonary and / or extrapulmonary causes.
Time frame: Within 30 days after cardiac surgery
delirium
Delirium refers to a group of syndromes, also known as acute brain syndrome. It is manifested as consciousness disorder, disorganized behavior, no purpose and unable to concentrate.
Time frame: Within 30 days after cardiac surgery
need for renal replacement therapy (RRT)
Replacement therapy usually includes hemodialysis, peritoneal dialysis and kidney transplantation.
Time frame: Within 30 days after cardiac surgery
need for hemodialysis
Hemodialysis (hd) is one of the renal replacement therapies for patients with acute and chronic renal failure.
Time frame: Within 30 days after cardiac surgery
incidence of readmission to ICU
The patients re-enters ICU.
Time frame: Within 30 days after cardiac surgery
length of ICU stay
From the day of surgery to the time the patient leaves the ICU.
Time frame: Within 30 days after cardiac surgery
length of stay
From the day of surgery to the time the patient leaves the hospital.
Time frame: Within 30 days after cardiac surgery
levels of serum antidiuretic hormone in patients
T1-T4 were defined as entering the operating room, 4, 12 and 24 hour postoperatively, respectively.
Time frame: at entering the operating room(T1), 4 hour(T2), 12 hour(T3) and 24 hour(T4) postoperatively
levels of copeptin in patients
T1-T4 were defined as entering the operating room, 4, 12 and 24 hour postoperatively, respectively.
Time frame: at entering the operating room(T1), 4 hour(T2), 12 hour(T3) and 24 hour(T4) postoperatively
secondary endotracheal intubation
Secondary endotracheal intubation refers to the second endotracheal intubation after the patient's postoperative endotracheal intubation is removed.
Time frame: Within 30 days after cardiac surgery
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