PMS Promotes the Recovery of Patients After Heart Valve Replacement

Heart Valve Diseases Clinical Trial

— PMS  

Official title:

Probiotic Mixture Supplementation (PMS) Promotes the Recovery of Patients After Heart Valve Replacement by Preventing Acute Gastrointestinal Injury (AGI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05498948
• Other study ID #: PMS
• Status: Completed
• Phase: N/A
• Start date: August 20, 2022
• Est. completion date: January 2, 2024

Study information

• Verified date: January 2024
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Patients with heart valve diseases often have chronic cardiac insufficiency. Accumulating evidence supports a relationship between the complexity and diversity of the gut microbiota and heart failure. Bacterial colonization and translocation of their toxins to the bloodstream due to altered intestinal permeability are directly correlated with systemic inflammation. The activation of pro-inflammatory pathways and chronic inflammation was hypothesized as a major contributing factor in the pathogenicity and progression of heart failure (HF) Patients undergoing heart valve replacement with cardiopulmonary bypass (CPB) are always complicated with gastrointestinal tract ischemia-reperfusion injury, which usually leads to AGI. AGI is related to poor outcomes of critically ill patients through many underlying mechanisms. It can leads to infectious complications, multiple organ dysfunction syndromes (MODS), and even death. On the other hand, the supply of probiotics, the good bacteria, is beneficial, despite still having a few controversial results. Therefore, it is important to carefully assess the efficacy of probiotics in the prevention of AGI and other complications in patients undergoing heart valve replacement surgery with CPB, as well as to evaluate the safety of its use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2, 2024
• Est. primary completion date: January 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Dietary Supplement:
• Probiotic mixture
orally take .

Locations

Country	Name	City	State
China	Hepatopancreatobiliary Surgery Institute of Gansu Province	Lanzhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

References & Publications (2)

Chen Y, Zhang F, Ye X, Hu JJ, Yang X, Yao L, Zhao BC, Deng F, Liu KX. Association Between Gut Dysbiosis and Sepsis-Induced Myocardial Dysfunction in Patients With Sepsis or Septic Shock. Front Cell Infect Microbiol. 2022 Mar 14;12:857035. doi: 10.3389/fci — View Citation

Pasini E, Aquilani R, Testa C, Baiardi P, Angioletti S, Boschi F, Verri M, Dioguardi F. Pathogenic Gut Flora in Patients With Chronic Heart Failure. JACC Heart Fail. 2016 Mar;4(3):220-7. doi: 10.1016/j.jchf.2015.10.009. Epub 2015 Dec 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The AGI score	The AGI score of the patient within the 7th postoperative day was performed according to the European Society of critical care (2012) guidelines for AGI.	1 month
Primary	Intra-abdominal pressure (IAP)	We defined it as the maximum value of intra-abdominal pressure within 7 days after surgery	1 month
Primary	Characteristics of gut microbiomes	Feces are collected with sterilized 2 ml tubes and frozen at -80 °C until DNA extraction, preparing for microbe analysis	1 month
Secondary	Return time of bowel sounds	The return time of bowel sounds will be evaluated morning and evening	1 month
Secondary	Number of bowel sounds	The number of bowel sounds will be evaluated morning and evening	1 month
Secondary	First defecation time	The time to the first defecation will be asked morning and evening after surgery	1 month
Secondary	Bristol Stool Form Scale score	Bristol Stool Form Scale is a medical aid designed to classify the form of stool with 7 levels	1 month
Secondary	Proportion of cocci and bacilli in feces	The first feces will be collected in sterile containers for the tertial smear	1 month
Secondary	Procalcitonin (PCT)	Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the PCT	1 month
Secondary	Interleukin-6	Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the Interleukin-6	1 month
Secondary	Interleukin-10	Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the Interleukin-10	1 month
Secondary	High sensitivity troponin(hs TnI)	Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the hs TnI	1 month
Secondary	N-terminal precursor brain natriuretic peptide(NT-ProBNP)	Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the NT-ProBNP	1 month
Secondary	Trimethylamine oxide(TMAO)	Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the TMAO	1 month
Secondary	Intestinal fatty acid-binding protein (IFABP)	Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the IFABP	1 month
Secondary	Left ventricular ejection fraction (LVEF)	Measure the LVEF on the 1st and 3rd days after operation by echocardiographic examinations	1 month