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Completed

NCT Number: NCT05498935

Prolonged Cardiopulmonary Bypass Time as a Predictive Factor for 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPB time

Other

Cardiopulmonary bypass time

Primary outcomes

  1. Cardiopulmonary bypass (CPB) time

    Time frame: 1 month

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

  2. 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

  1. Number of bowel sounds

    Time frame: 1 month

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

  2. First defecation time

    Time frame: 1 month

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

  3. Proportion of cocci and bacilli in feces

    Time frame: 1 month

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

  4. Alanine aminotransferase (ALT)

    Time frame: 1 month

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

  5. Aspartate aminotransferase (AST)

    Time frame: 1 month

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

  6. Left ventricular ejection fraction (LVEF)

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2022
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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