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The Effect of Pituitrin on the Patients With Pulmonary Hypertension Undergoing Cardiac Surgery

Primary Purpose

Cardiac Surgery, Hypertension, Pulmonary

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pituitrin
normal saline
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Surgery focused on measuring cardiac surgery, Hypertension, Pulmonary, Pituitary Hormones, Posterior, Extracorporeal Circulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age ≥18 years and ≤80 years; scheduled for elective cardiopulmonary bypass heart surgery (adult congenital heart disease surgery, coronary artery bypass grafting, valve replacement, valvuloplasty, heart transplantation and aortic surgery); Patients who had pulmonary hypertension (Mean pulmonary artery pressure at rest ≥ 25mmhg or pulmonary artery systolic pressure (PASP) ≥ 40mmhg as shown by echocardiography); sign informed consent. Exclusion Criteria: use pituitrin or vasopressin before operation; Patients who had acute coronary syndrome; preoperative use of left ventricular assist devices other than intra aortic balloon - pump (IABP); Patients who had liver, thyroid and adrenal diseases, severe lung diseases, diabetes; Patients who had preoperative renal insufficiency (The increase of serum creatinine (SCR) within 48 h ≥ 0.3mg/dl (or ≥ 26.5 μ mol/L); Or it is known or speculated that the increase of SCR in the past 7 days is more than 1.5 times of the basic value; Or 0.5ml/kg urine volume per hour for 6H); Patients who had severe carotid artery stenosis, preoperative stroke, mental disorder and other difficult to communicate and cooperate; Patients who had peripheral vascular disease, allergy to vasopressin or pituitrin, severe hyponatremia (na+ < 130 mmol/l), acute mesenteric ischemia, pregnancy, malignant tumors, required ECMO and underwent emergency surgery or reoperation; Patients who had participated in other clinical studies in recent 3 months.

Sites / Locations

  • Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pituitrin group

normal saline group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

incidence of postoperative infection
The patient appears infection after surgery.
septic shock
Septic shock was defined as the septic syndrome with shock caused by microorganisms and their toxins.
duration of mechanical ventilation
Total duration of mechanical ventilation during or after 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 to achieve hemodynamic stability
From hemodynamic change to hemodynamic stability.
use of dobutamine or other vasoactive drugs
The patients use dobutamine or other vasoactive drugs.
incidence of digital ischemia
Digital ischemia is a symptom caused by insufficient blood supply to the fingers.
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.
gastrointestinal complications
Including dyspepsia, abdominal distension, constipation, postoperative stress ulcer, gastrointestinal bleeding, etc.
incidence of acute myocardial infarction
Acute myocardial infarction is myocardial necrosis caused by acute and persistent ischemia and hypoxia of coronary artery.
new onset tachyarrhythmia
Tachyarrhythmia includes premature beat, tachycardia, atrial fibrillation and ventricular fibrillation, etc.
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.
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.
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.
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.
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.
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.
need for renal replacement therapy (RRT)
Replacement therapy usually includes hemodialysis, peritoneal dialysis and kidney transplantation.
need for hemodialysis
Hemodialysis (hd) is one of the renal replacement therapies for patients with acute and chronic renal failure.
incidence of readmission to ICU
The patients re-enters ICU.
length of ICU stay
From the day of surgery to the time the patient leaves the ICU.
length of stay
From the day of surgery to the time the patient leaves the hospital.
levels of serum antidiuretic hormone in patients
T1-T4 were defined as entering the operating room, 4, 12 and 24 hour postoperatively, respectively.
levels of copeptin in patients
T1-T4 were defined as entering the operating room, 4, 12 and 24 hour postoperatively, respectively.
secondary endotracheal intubation
Secondary endotracheal intubation refers to the second endotracheal intubation after the patient's postoperative endotracheal intubation is removed.

Full Information

First Posted
January 16, 2023
Last Updated
February 5, 2023
Sponsor
Qianfoshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05727618
Brief Title
The Effect of Pituitrin on the Patients With Pulmonary Hypertension Undergoing Cardiac Surgery
Official Title
The Effect of Pituitrin on Postoperative Outcomes in Patients With Pulmonary Hypertension Undergoing Cardiac Surgery: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qianfoshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery, Hypertension, Pulmonary
Keywords
cardiac surgery, Hypertension, Pulmonary, Pituitary Hormones, Posterior, Extracorporeal Circulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pituitrin group
Arm Type
Experimental
Arm Description
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).
Arm Title
normal saline group
Arm Type
Placebo Comparator
Arm Description
Intravenous infusion of normal saline at the same dose and speed
Intervention Type
Drug
Intervention Name(s)
Pituitrin
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
Intravenous infusion of normal saline at the same dose and speed
Primary Outcome Measure Information:
Title
a composite endpoint of mortality or severe postoperative complications
Description
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
Secondary Outcome Measure Information:
Title
incidence of postoperative infection
Description
The patient appears infection after surgery.
Time Frame
Within 30 days after cardiac surgery
Title
septic shock
Description
Septic shock was defined as the septic syndrome with shock caused by microorganisms and their toxins.
Time Frame
Within 30 days after cardiac surgery
Title
duration of mechanical ventilation
Description
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.
Title
postoperative pulmonary complications
Description
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
Title
time to achieve hemodynamic stability
Description
From hemodynamic change to hemodynamic stability.
Time Frame
Within 30 days after cardiac surgery
Title
use of dobutamine or other vasoactive drugs
Description
The patients use dobutamine or other vasoactive drugs.
Time Frame
Within 30 days after cardiac surgery
Title
incidence of digital ischemia
Description
Digital ischemia is a symptom caused by insufficient blood supply to the fingers.
Time Frame
Within 30 days after cardiac surgery
Title
acute mesenteric ischemia
Description
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
Title
gastrointestinal complications
Description
Including dyspepsia, abdominal distension, constipation, postoperative stress ulcer, gastrointestinal bleeding, etc.
Time Frame
Within 30 days after cardiac surgery
Title
incidence of acute myocardial infarction
Description
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
Title
new onset tachyarrhythmia
Description
Tachyarrhythmia includes premature beat, tachycardia, atrial fibrillation and ventricular fibrillation, etc.
Time Frame
Within 30 days after cardiac surgery
Title
water poisoning
Description
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
Title
vasodilative shock
Description
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
Title
incidence of pulmonary embolism
Description
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
Title
low cardiac output syndrome
Description
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
Title
acute respiratory distress syndrome
Description
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
Title
delirium
Description
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
Title
need for renal replacement therapy (RRT)
Description
Replacement therapy usually includes hemodialysis, peritoneal dialysis and kidney transplantation.
Time Frame
Within 30 days after cardiac surgery
Title
need for hemodialysis
Description
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
Title
incidence of readmission to ICU
Description
The patients re-enters ICU.
Time Frame
Within 30 days after cardiac surgery
Title
length of ICU stay
Description
From the day of surgery to the time the patient leaves the ICU.
Time Frame
Within 30 days after cardiac surgery
Title
length of stay
Description
From the day of surgery to the time the patient leaves the hospital.
Time Frame
Within 30 days after cardiac surgery
Title
levels of serum antidiuretic hormone in patients
Description
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
Title
levels of copeptin in patients
Description
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
Title
secondary endotracheal intubation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age ≥18 years and ≤80 years; scheduled for elective cardiopulmonary bypass heart surgery (adult congenital heart disease surgery, coronary artery bypass grafting, valve replacement, valvuloplasty, heart transplantation and aortic surgery); Patients who had pulmonary hypertension (Mean pulmonary artery pressure at rest ≥ 25mmhg or pulmonary artery systolic pressure (PASP) ≥ 40mmhg as shown by echocardiography); sign informed consent. Exclusion Criteria: use pituitrin or vasopressin before operation; Patients who had acute coronary syndrome; preoperative use of left ventricular assist devices other than intra aortic balloon - pump (IABP); Patients who had liver, thyroid and adrenal diseases, severe lung diseases, diabetes; Patients who had preoperative renal insufficiency (The increase of serum creatinine (SCR) within 48 h ≥ 0.3mg/dl (or ≥ 26.5 μ mol/L); Or it is known or speculated that the increase of SCR in the past 7 days is more than 1.5 times of the basic value; Or 0.5ml/kg urine volume per hour for 6H); Patients who had severe carotid artery stenosis, preoperative stroke, mental disorder and other difficult to communicate and cooperate; Patients who had peripheral vascular disease, allergy to vasopressin or pituitrin, severe hyponatremia (na+ < 130 mmol/l), acute mesenteric ischemia, pregnancy, malignant tumors, required ECMO and underwent emergency surgery or reoperation; Patients who had participated in other clinical studies in recent 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quan Li, doctor
Phone
13964017257
Email
liquann@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meng Lv, doctor
Phone
15169105373
Email
qylvmeng@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quan Li, doctor
Organizational Affiliation
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meng Lv, doctor
Organizational Affiliation
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Pituitrin on the Patients With Pulmonary Hypertension Undergoing Cardiac Surgery

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