Prolonged Cardiopulmonary Bypass Time as a Predictive Factor for AGI After Heart Valve Replacement

Completed

• Conditions: Heart Valve Diseases
• Interventions: Other: CPB time

• Registration Number: NCT05498935
• Lead Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

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.

Study Timeline

• Study Start: 2022-08-10
• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Status Verified: 2024-01
• Primary Completion: 2024-01-02
• Study Completion: 2024-01-02
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1070

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
• Abdominal hernia
• Irritable bowel syndrome
• Acute or chronic cholecystitis, hepatitis
• Patients who died during surgery
• Patients with digestive system tumors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CPB time ≥ 90 minutes	CPB time	No intervention, regular therapy
CPB time < 90 minutes	CPB time	No intervention, regular therapy

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary bypass (CPB) time	1 month	Was defined it as the sum of times of CPB during surgery (minutes).
The AGI score	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 Outcome Measures

Name	Time	Method
Number of bowel sounds	1 month	The return time of bowel sounds was evaluated morning and evening.
Proportion of cocci and bacilli in feces	1 month	The first feces were collected in sterile containers for the bacterial smear
First defecation time	1 month	The time to the first defecation was asked morning and evening after surgery
Alanine aminotransferase (ALT)	1 month	We defined it as the maximum value of ALT within 7 days after surgery.
Aspartate aminotransferase (AST)	1 month	We defined it as the maximum value of AST within 7 days after surgery
Left ventricular ejection fraction (LVEF)	1 month	We measured the LVEF on the 1st and 3rd days after operation by echocardiographic examinations

Trial Locations

Locations (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province; 🇨🇳 Lanzhou, Gansu, China