Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000, China
NCT Number: NCT05498948
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).
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Lanzhou, Gansu, 730000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
orally take .
Time frame: 1 month
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.
Time frame: 1 month
We defined it as the maximum value of intra-abdominal pressure within 7 days after surgery
Time frame: 1 month
Feces are collected with sterilized 2 ml tubes and frozen at -80 °C until DNA extraction, preparing for microbe analysis
Time frame: 1 month
The return time of bowel sounds will be evaluated morning and evening
Time frame: 1 month
The number of bowel sounds will be evaluated morning and evening
Time frame: 1 month
The time to the first defecation will be asked morning and evening after surgery
Time frame: 1 month
Bristol Stool Form Scale is a medical aid designed to classify the form of stool with 7 levels
Time frame: 1 month
The first feces will be collected in sterile containers for the tertial smear
Time frame: 1 month
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the PCT
Time frame: 1 month
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the Interleukin-6
Time frame: 1 month
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the Interleukin-10
Time frame: 1 month
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the hs TnI
Time frame: 1 month
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the NT-ProBNP
Time frame: 1 month
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the TMAO
Time frame: 1 month
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the IFABP
Time frame: 1 month
Measure the LVEF on the 1st and 3rd days after operation by echocardiographic examinations
Hepatopancreatobiliary Surgery Institute of Gansu Province
Other
Probiotic Mixture Supplementation (PMS) Promotes the Recovery of Patients After Heart Valve Replacement by Preventing Acute Gastrointestinal Injury (AGI)
Acronym: PMS
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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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