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Clinical Trials/NCT05498935
NCT05498935
Completed
Not Applicable

Prolonged Cardiopulmonary Bypass (CPB) Time as a Predictive Factor for Acute Gastrointestinal Injury (AGI) After Heart Valve Replacement

Hepatopancreatobiliary Surgery Institute of Gansu Province1 site in 1 country1,070 target enrollmentAugust 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Valve Diseases
Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
Enrollment
1070
Locations
1
Primary Endpoint
Cardiopulmonary bypass (CPB) time
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

In this retrospective study, the investigators will analyze the correlation between cardiopulmonary bypass (CPB) time and acute gastrointestinal injury (AGI), and the outcomes of AGI in patients undergoing heart valve replacement.

Detailed Description

Patients with heart valve diseases often have chronic cardiac insufficiency. Patients undergoing heart valve replacement with CPB are always complicated with gastrointestinal tract ischemia-reperfusion injury, which usually leads to AGI. AGI after cardiovascular surgery, especially in that use CPB, is associated with significant morbidity and an increase in peri-operative mortality. Prolonged CPB time could be predictive of AGI following heart valve replacement. This study is to analyze the correlation between CPB time and AGI, and the outcomes of AGI in patients undergoing heart valve replacement. The investigators hope that the benefits will include fewer patients becoming seriously postoperative AGI and mortality after cardiac surgery.

Registry
clinicaltrials.gov
Start Date
August 10, 2022
End Date
January 2, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
Responsible Party
Principal Investigator
Principal Investigator

Wenbo Meng

Professor of Surgery

Hepatopancreatobiliary Surgery Institute of Gansu Province

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing heart valve replacement surgery with CPB
  • Age \> 18 years and ≤ 70 years

Exclusion Criteria

  • Patients combined with severe hematological disease, respiratory disease, and other critical diseases
  • Patients had severe disorder of multiple systems and organs or severe pulmonary hypertension
  • Have received major gastrointestinal surgery within 5 years
  • Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis
  • Acute gastroenteritis
  • Clostridium difficile or Helicobacter pylori infection
  • Chronic constipation
  • Peptic ulcer
  • Polyps in the stomach or intestines
  • Gastrointestinal neoplasms

Outcomes

Primary Outcomes

Cardiopulmonary bypass (CPB) time

Time Frame: 1 month

Was defined it as the sum of times of CPB during surgery (minutes).

The AGI score

Time Frame: 1 month

The AGI score of the patient within the seventh postoperative day was performed according to the European Society of critical care (2012) guidelines for AGI.

Secondary Outcomes

  • Number of bowel sounds(1 month)
  • Proportion of cocci and bacilli in feces(1 month)
  • First defecation time(1 month)
  • Alanine aminotransferase (ALT)(1 month)
  • Aspartate aminotransferase (AST)(1 month)
  • Left ventricular ejection fraction (LVEF)(1 month)

Study Sites (1)

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