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Optimal Clinical Predictors to AKI in Cirrhotic Patients Experienced Acute Gastrointestinal Hemorrhage (ABC(AKI-B))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04184934
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

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.

Condition or disease
Gastrointestinal Hemorrhage Liver Cirrhosis Acute Kidney Injury

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Weeks
Official Title: Optimal Clinical Predictors to Acute Kidney Injury in Cirrhotic Patients Experienced Acute Gastrointestinal Hemorrhage
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Mortality [ Time Frame: 6 weeks ]
    Inpatient mortality rate

  2. Incidence rates of AKI [ Time Frame: 6 weeks ]
    Incidence rates of AKI in patient suffering from acute gastrointestinal hemorrhage


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).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients less than 20 years old.
  2. Patients with antecedent or ongoing active malignancy.
  3. 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.
  4. Patients with severe hyperbilirubinemia with total bilirubin > 10mg/dL.
  5. Patients who underwent trans-jugular intrahepatic portosystemic shunt.
  6. Patients who are pregnant or breastfeeding.
  7. Patients who refuse to join the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04184934


Contacts
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Contact: Ming-Chih Hou, MD 886-2-28712111 ext 7877 mchou@vghtpe.gov.tw
Contact: Pei-Chang Lee, MD 886-2-28712111 ext 3972 pclee7@vghtpe.gov.tw

Locations
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Taiwan
Taipei Veterans General Hospital, Taiwan Recruiting
Taipei, Taiwan, 11217
Contact: Ming-Chih Hou, MD    886-2-28712121 ext 7506    mchou@vghtpe.gov.tw   
Principal Investigator: Ming-Chih Hou, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Ming-Chih Hou, MD Taipei Veterans General Hospital, Taiwan
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Responsible Party: vghtpe user, Taipei Veterans General Hospital, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT04184934    
Other Study ID Numbers: 2018-07-044BC
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:
Liver cirrhosis
Gastrointestinal hemorrhage
Acute Kidney injury
Predictors
Additional relevant MeSH terms:
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Liver Cirrhosis
Gastrointestinal Hemorrhage
Acute Kidney Injury
Hemorrhage
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Gastrointestinal Diseases