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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Valve Diseases
• Intervention / Treatment: Other: CPB time

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 Type: Observational
• Enrollment (Actual): 1070

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Hepatopancreatobiliary Surgery Institute of Gansu Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Heart valve diseases

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CPB time ≥ 90 minutes; No intervention, regular therapy	Other: CPB time; Cardiopulmonary bypass time
CPB time < 90 minutes; No intervention, regular therapy	Other: CPB time; Cardiopulmonary bypass time

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Investigators: Principal Investigator: Wenbo Meng, M.D. Ph.D, LanZhou University

Publications and helpful links

General Publications

• Gallitto E, Sobocinski J, Mascoli C, Pini R, Fenelli C, Faggioli G, Haulon S, Gargiulo M. Fenestrated and Branched Thoraco-abdominal Endografting after Previous Open Abdominal Aortic Repair. Eur J Vasc Endovasc Surg. 2020 Dec;60(6):843-852. doi: 10.1016/j.ejvs.2020.07.071. Epub 2020 Aug 24.
• Buchbinder A, Adler H, Ballard H. An unusual and unreported toxicity to erythropoietin. Am J Hematol. 1993 Apr;42(4):412-3. doi: 10.1002/ajh.2830420428. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): January 2, 2024
• Study Completion (Actual): January 2, 2024

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Gastrointestinal tract; Heart valve diseases
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases
• Other Study ID Numbers: CPB-AGI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If patients permitted

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No