PMS Promotes the Recovery of Patients After Heart Valve Replacement (NCT05498948) | Clinical Trial Compass
CompletedNot Applicable
PMS Promotes the Recovery of Patients After Heart Valve Replacement
China52 participantsStarted 2022-08-20
Plain-language summary
Acute gastrointestinal injury (AGI) is related to poor outcomes in patients after heart valve replacement. The purpose of this study is to evaluate the effect of the probiotic mixture supplementation (PMS) in patients after heart valve replacement by preventing acute gastrointestinal injury (AGI).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Moderate to severe congestive heart failure (CHF) (NYHA functional class III to IV)
* Patients with heart valve diseases undergoing CPB cardiac surgery
* Age \> 18 years and ≤ 70 years
Exclusion Criteria:
* Patients with severe low left ventricular function: LVEF ≤ 30%
* Patients with infective endocarditis
* Have received major gastrointestinal surgery (including gallbladder and appendectomy) 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
* Used antibiotics and probiotics in the past 1 month
* Patients used antidiarrheals, laxatives, or prebiotics within 1 week
* Pregnant or pregnant during follow-up
* Failure to give informed consent (e.g. severe cognitive impairment)
* The patient has been enrolled in other ongoing clinical trials
What they're measuring
1
The AGI score
Timeframe: 1 month
2
Intra-abdominal pressure (IAP)
Timeframe: 1 month
3
Characteristics of gut microbiomes
Timeframe: 1 month
Trial details
NCT IDNCT05498948
SponsorHepatopancreatobiliary Surgery Institute of Gansu Province