Cardiac SurgeryNCT05727618
The Effect of Pituitrin on the Patients With Pulmonary Hypertension Undergoing Cardiac Surgery
A study testing Pituitrin and normal saline in people with Cardiac Surgery and Hypertension, Pulmonary, run by Qianfoshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery, Hypertension, Pulmonary
- What is being tested?
- Pituitrin and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, 250000
About this study
Official title: The Effect of Pituitrin on Postoperative Outcomes in Patients With Pulmonary Hypertension Undergoing Cardiac Surgery: a Randomized Controlled Study
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).
Read the 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.
- Conditions
- Cardiac Surgery, Hypertension, Pulmonary
- Being tested
- Pituitrin, normal saline
- Keywords
- cardiac surgery, Hypertension, Pulmonary, Pituitary Hormones, Posterior, Extracorporeal Circulation
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PituitrinDrug
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).
normal salineDrug
Intravenous infusion of normal saline at the same dose and speed
| Study group | Role | What they receive |
|---|---|---|
| pituitrin group | Experimental | 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). Receives: Drug: Pituitrin |
| normal saline group | Placebo comparator | Intravenous infusion of normal saline at the same dose and speed Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 30 days after cardiac surgery
Secondary outcomes (25)
incidence of postoperative infection
The patient appears infection after surgery.
Measured: Within 30 days after cardiac surgery
septic shock
Septic shock was defined as the septic syndrome with shock caused by microorganisms and their toxins.
Measured: Within 30 days after cardiac surgery
duration of mechanical ventilation
Total duration of mechanical ventilation during or after surgery.
Measured: 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.
Measured: Within 30 days after cardiac surgery
time to achieve hemodynamic stability
From hemodynamic change to hemodynamic stability.
Measured: Within 30 days after cardiac surgery
use of dobutamine or other vasoactive drugs
The patients use dobutamine or other vasoactive drugs.
Measured: Within 30 days after cardiac surgery
incidence of digital ischemia
Digital ischemia is a symptom caused by insufficient blood supply to the fingers.
Measured: 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.
Measured: Within 30 days after cardiac surgery
gastrointestinal complications
Including dyspepsia, abdominal distension, constipation, postoperative stress ulcer, gastrointestinal bleeding, etc.
Measured: 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.
Measured: Within 30 days after cardiac surgery
new onset tachyarrhythmia
Tachyarrhythmia includes premature beat, tachycardia, atrial fibrillation and ventricular fibrillation, etc.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 30 days after cardiac surgery
need for renal replacement therapy (RRT)
Replacement therapy usually includes hemodialysis, peritoneal dialysis and kidney transplantation.
Measured: 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.
Measured: Within 30 days after cardiac surgery
incidence of readmission to ICU
The patients re-enters ICU.
Measured: Within 30 days after cardiac surgery
length of ICU stay
From the day of surgery to the time the patient leaves the ICU.
Measured: Within 30 days after cardiac surgery
length of stay
From the day of surgery to the time the patient leaves the hospital.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 30 days after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start1 May 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Why it stopped: The clinical research protocol failed to obtain approval from the Institutional Review Board (IRB).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng Lv, Qianfoshan Hospital
- Investigators
- Quan Li, doctor, Principal investigator, Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical UniversityMeng Lv, doctor, Principal investigator, Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727618
- Sponsor's protocol ID
- LM-KLC-2022
- Status last verified
- Mar 2025
- First submitted
- 16 Jan 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pituitrin on Postoperative Outcomes in Patients With Pulmonary Hypertension Undergoing Cardiac Surgery: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05727618
- Acronym / sponsor ID
- LM-KLC-2022
- Conditions
- Cardiac Surgery, Hypertension, Pulmonary
- Keywords
- cardiac surgery, Hypertension, Pulmonary, Pituitary Hormones, Posterior, Extracorporeal Circulation
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The clinical research protocol failed to obtain approval from the Institutional Review Board (IRB).
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pituitrin group | Experimental | Drug: PituitrinThe 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). |
| normal saline group | Placebo comparator | Drug: normal salineIntravenous infusion of normal saline at the same dose and speed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PituitrinThe 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). | Drug | pituitrin group |
| normal salineIntravenous infusion of normal saline at the same dose and speed | Drug | normal saline group |
Primary outcome
a composite endpoint of mortality or severe postoperative complications
Time frame: Within 30 days after cardiac surgery
severe complications after cardiac surgery, including stroke, requirement of mechanical ventilation for longer than 48h, deep sternal wound infection, reoperation, or acute renal failure
25 secondary outcomes
incidence of postoperative infection
Time frame: Within 30 days after cardiac surgery
septic shock
Time frame: Within 30 days after cardiac surgery
duration of mechanical ventilation
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
Time frame: Within 30 days after cardiac surgery
time to achieve hemodynamic stability
Time frame: Within 30 days after cardiac surgery
use of dobutamine or other vasoactive drugs
Time frame: Within 30 days after cardiac surgery
incidence of digital ischemia
Time frame: Within 30 days after cardiac surgery
acute mesenteric ischemia
Time frame: Within 30 days after cardiac surgery
gastrointestinal complications
Time frame: Within 30 days after cardiac surgery
incidence of acute myocardial infarction
Time frame: Within 30 days after cardiac surgery
new onset tachyarrhythmia
Time frame: Within 30 days after cardiac surgery
water poisoning
Time frame: Within 30 days after cardiac surgery
vasodilative shock
Time frame: Within 30 days after cardiac surgery
incidence of pulmonary embolism
Time frame: Within 30 days after cardiac surgery
low cardiac output syndrome
Time frame: Within 30 days after cardiac surgery
acute respiratory distress syndrome
Time frame: Within 30 days after cardiac surgery
delirium
Time frame: Within 30 days after cardiac surgery
need for renal replacement therapy (RRT)
Time frame: Within 30 days after cardiac surgery
need for hemodialysis
Time frame: Within 30 days after cardiac surgery
incidence of readmission to ICU
Time frame: Within 30 days after cardiac surgery
length of ICU stay
Time frame: Within 30 days after cardiac surgery
length of stay
Time frame: Within 30 days after cardiac surgery
levels of serum antidiuretic hormone in patients
Time frame: at entering the operating room(T1), 4 hour(T2), 12 hour(T3) and 24 hour(T4) postoperatively
levels of copeptin in patients
Time frame: at entering the operating room(T1), 4 hour(T2), 12 hour(T3) and 24 hour(T4) postoperatively
secondary endotracheal intubation
Time frame: Within 30 days after cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quan Li, doctor principal investigator
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Meng Lv, doctor principal investigator
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pituitrin and normal saline in people with Cardiac Surgery and Hypertension, Pulmonary, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a composite endpoint of mortality or severe postoperative complications (time frame: Within 30 days after cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.