Optimal Clinical Predictors to AKI in Cirrhotic Patients Experienced Acute Gastrointestinal Hemorrhage

NCT04184934 | Unknown

• 1 other identifier: 2018-07-044BC
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Acute kidney injury (AKI) is a common complication, occurring in approximately 20% of hospitalized cirrhotic patients and has a significant negative impact on patients' outcomes according to either the initial stage (at the time of the first fulfillment of AKI criteria), or the peak stage (at the peak value of serum creatinine concentration during hospitalization). Among all the precipitating factors to cirrhotic AKI, acute gastrointestinal hemorrhage is a common cause that leads to a decrease in effective arterial blood volume in the hyperdynamic circulatory status of cirrhosis. However, there is still lack of optimal predictors to developing AKI in cirrhotic patients suffering from acute GI bleeding. A number of biomarkers associated with AKI were recently described. Some studies have shown that these novel biomarkers increase with the severity of liver injury and are predictive of clinical outcomes. However, the effective prediction, definitive diagnosis and differentiation of AKI by these biomarkers are still controversial. Furthermore, there is no clinical studies focus on the applicability and potential alteration in the setting of acute gastrointestinal hemorrhage in patients with cirrhosis. Aim and significance: In this study, we aim to investigate the capability of novel renal biomarkers in predicting development of acute kidney injury, differentiating causes (between pre-renal AKI, acute tubular necrosis, and hepatorenal syndrome), and predicting the response to renal treatment as well as the hepatic and overall outcomes in patients with cirrhosis suffering from acute gastrointestinal hemorrhage.

Conditions

Gastrointestinal Hemorrhage; Liver Cirrhosis; Acute Kidney Injury

Keywords

Liver cirrhosis; Gastrointestinal hemorrhage; Acute Kidney injury; Predictors

Outcome Measures

Primary Outcomes (2)

• Mortality

  Inpatient mortality rate

  6 weeks

• Incidence rates of AKI

  Incidence rates of AKI in patient suffering from acute gastrointestinal hemorrhage

  6 weeks

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive adult cirrhotic patients admitted to Taipei Veterans General Hospital for suffering from acute gastrointestinal hemorrhage without intervention within 3 days

You may qualify if:

• Consecutive adult cirrhotic patients admitted to Taipei Veterans General Hospital for suffering from acute gastrointestinal hemorrhage without intervention within 3 days

You may not qualify if:

• Patients less than 20 years old.
• Patients with antecedent or ongoing active malignancy.
• Patients with human immunodeficiency virus coinfection or severe comorbidities, such as end-stage renal disease or uremia without regular dialysis, recent acute coronary syndrome or stroke, severe heart failure, severe arrhythmia, and major trauma.
• Patients with severe hyperbilirubinemia with total bilirubin \> 10mg/dL.
• Patients who underwent trans-jugular intrahepatic portosystemic shunt.
• Patients who are pregnant or breastfeeding.
• Patients who refuse to join the study.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital, Taiwan

Taipei, 11217, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

A fresh 30-mL of urine sample will be collected either by way of clean catch or Foley catheter tubing will be collected at the time in admission to our hospital, at the peak stage of AKI, and after the recovery (if recovery occurs). 10cc of blood will be collected from the peripheral vessel once at the time in admission to our hospital, at the peak stage of AKI, and after the recovery (if recovery occurs).

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Liver Cirrhosis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Fibrosis; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ming-Chih Hou, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Chih Hou, MD

CONTACT

886-2-28712111; mchou@vghtpe.gov.tw

Pei-Chang Lee, MD

CONTACT

886-2-28712111; pclee7@vghtpe.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Taipei Veterans General Hospital

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 4, 2019
• Study Start: January 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: January 30, 2021
• Last Updated: July 21, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)