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

NCT05727618 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-03-20

No results posted yet for this study

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

Interventions

DRUG

Pituitrin

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

normal saline

Intravenous infusion of normal saline at the same dose and speed

Sponsors & Collaborators

  • Qianfoshan Hospital

    lead OTHER

Principal Investigators

  • Quan Li, doctor · Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

  • Meng Lv, doctor · Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-12-01
Completion
2029-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05727618 on ClinicalTrials.gov