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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05498935
Enrollment
1070
Registered
2022-08-12
Start date
2022-08-10
Completion date
2024-01-02
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Diseases

Keywords

Heart valve diseases, Gastrointestinal tract

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.

Interventions

OTHERCPB time

Cardiopulmonary bypass time

Sponsors

Hepatopancreatobiliary Surgery Institute of Gansu Province
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Cardiopulmonary bypass (CPB) time1 monthWas defined it as the sum of times of CPB during surgery (minutes).
The AGI score1 monthThe 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

MeasureTime frameDescription
Proportion of cocci and bacilli in feces1 monthThe first feces were collected in sterile containers for the bacterial smear
Alanine aminotransferase (ALT)1 monthWe defined it as the maximum value of ALT within 7 days after surgery.
Number of bowel sounds1 monthThe return time of bowel sounds was evaluated morning and evening.
Left ventricular ejection fraction (LVEF)1 monthWe measured the LVEF on the 1st and 3rd days after operation by echocardiographic examinations
Aspartate aminotransferase (AST)1 monthWe defined it as the maximum value of AST within 7 days after surgery
First defecation time1 monthThe time to the first defecation was asked morning and evening after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026