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CompletedNCT05498935Updated Jan 3, 2024

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

An observational study in Heart Valve Diseases, sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
1,070
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Heart Valve Diseases

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Keywords

  • Heart valve diseases
  • Gastrointestinal tract
03

In context

Heart Valve Diseases

535 studies on the registry are indexed under Heart Valve Diseases; 173 are open to participants now.

This study's enrollment of 1,070 is above the median of 300 across 232 observational studies indexed under Heart Valve Diseases.

Browse Heart Valve Diseases studies →

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province is the lead sponsor of 41 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Heart valve diseases

Inclusion criteria

  • Patients undergoing heart valve replacement surgery with CPB
  • Age > 18 years and ≤ 70 years

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
1,070 participants (actual)
Patient registry
No

Groups and cohorts

  • CPB time ≥ 90 minutes

    No intervention, regular therapy

    Other: CPB time

  • CPB time < 90 minutes

    No intervention, regular therapy

    Other: CPB time

Interventions

  • OtherCPB time

    Cardiopulmonary bypass time

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What researchers measure

Primary outcomes

  1. Cardiopulmonary bypass (CPB) time

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

    Time frame: 1 month

  2. 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.

    Time frame: 1 month

Secondary outcomes

  1. Number of bowel sounds

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

    Time frame: 1 month

  2. First defecation time

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

    Time frame: 1 month

  3. Proportion of cocci and bacilli in feces

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

    Time frame: 1 month

  4. Alanine aminotransferase (ALT)

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

    Time frame: 1 month

  5. Aspartate aminotransferase (AST)

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

    Time frame: 1 month

  6. Left ventricular ejection fraction (LVEF)

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

    Time frame: 1 month

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Study locations

1 site
  • Hepatopancreatobiliary Surgery Institute of Gansu Province
    Lanzhou, Gansu 730000, China
08

References and documents

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. PubMed 32855033 ↗
  • 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. PubMed 8494005 ↗

Individual participant data

Plan to share: Undecided — If patients permitted

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05498935
Lead sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
Responsible party
Wenbo Meng (Professor of Surgery, Hepatopancreatobiliary Surgery Institute of Gansu Province) — Principal investigator
First posted
Aug 12, 2022
Start date
Aug 10, 2022
Primary completion
Jan 2, 2024
Completion
Jan 2, 2024
Last update
Jan 3, 2024

Study contacts

Wenbo Meng, M.D. Ph.D
principal investigator · LanZhou University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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