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

NCT05727618 | Suspended

• 1 other identifier: LM-KLC-2022
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiac Surgery; Hypertension, Pulmonary

Keywords

cardiac surgery; Hypertension, Pulmonary; Pituitary Hormones, Posterior; Extracorporeal Circulation

Outcome Measures

Primary Outcomes (1)

• 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

  Within 30 days after cardiac surgery

Secondary Outcomes (25)

• incidence of postoperative infection

  Within 30 days after cardiac surgery

• septic shock

  Within 30 days after cardiac surgery

• duration of mechanical ventilation

  Time from the beginning of mechanical ventilation to the end of mechanical ventilation up to 30 days after cardiac surgery.

• postoperative pulmonary complications

  Within 30 days after cardiac surgery

• time to achieve hemodynamic stability

  Within 30 days after cardiac surgery

Study Arms (2)

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).

Drug: Pituitrin

normal saline group

PLACEBO COMPARATOR

Intravenous infusion of normal saline at the same dose and speed

Drug: normal saline

Interventions

Pituitrin DRUG

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).

pituitrin group

normal saline DRUG

Intravenous infusion of normal saline at the same dose and speed

normal saline group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

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

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Pituitary Hormones, Posterior; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Quan Li, doctor

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

  PRINCIPAL INVESTIGATOR

• Meng Lv, doctor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 14, 2023
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)