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

Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province (Other)
Overall Status
Recruiting
CT.gov ID
NCT05498935
Collaborator
(none)
1,400
1
4.7
295.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
1400 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Prolonged Cardiopulmonary Bypass (CPB) Time as a Predictive Factor for Acute Gastrointestinal Injury (AGI) After Heart Valve Replacement
Actual Study Start Date :
Aug 10, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Cardiopulmonary bypass (CPB) time [1 month]

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

  2. 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

  1. Number of bowel sounds [1 month]

    The return time of bowel sounds was evaluated morning and evening.

  2. First defecation time [1 month]

    The time to the first defecation was asked morning and evening after surgery

  3. Proportion of cocci and bacilli in feces [1 month]

    The first feces were collected in sterile containers for the bacterial smear

  4. Alanine aminotransferase (ALT) [1 month]

    We defined it as the maximum value of ALT within 7 days after surgery.

  5. Aspartate aminotransferase (AST) [1 month]

    We defined it as the maximum value of AST within 7 days after surgery

  6. Left ventricular ejection fraction (LVEF) [1 month]

    We measured the LVEF on the 1st and 3rd days after operation by echocardiographic examinations

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hepatopancreatobiliary Surgery Institute of Gansu Province Lanzhou Gansu China 730000

Sponsors and Collaborators

  • Hepatopancreatobiliary Surgery Institute of Gansu Province

Investigators

  • Principal Investigator: Wenbo Meng, M.D. Ph.D, LanZhou University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wenbo Meng, Professor of Surgery, Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier:
NCT05498935
Other Study ID Numbers:
  • CPB-AGI
First Posted:
Aug 12, 2022
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wenbo Meng, Professor of Surgery, Hepatopancreatobiliary Surgery Institute of Gansu Province
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2022