Multidiscipline Care for Acute Kidney Disease (AKD)

NCT05064904 | Unknown

• 2 other identifiers: 201811079MINC201900796A3C502
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 7

Brief Summary

The Taiwan Consortium of Acute Kidney Injury and Renal Diseases (TCTC) is leading a clinical trial group in Asia-Pacific to reduce the morbidity and mortality associated with acute kidney injury (AKI). The trial is a double two-by-two factorial design that will collect demographic and clinical information of AKI stage 2, 3, or weaning from dialysis-requiring AKI patients (AKI-D) to explore the epidemiology, risk factors and prognosis of AKI in Taiwan. Patients will be randomized either to add Angiotensin-Converting Enzyme Inhibitors (ACE-I)/Angiotensin II Receptor Blocker (ARB) to slow kidney function progression, or to receive multidisciplinary care. Patients will be followed up for a minimum of 6 months to evaluate kidney function, the predictability of developing chronic kidney disease, end stage renal disease, major cardiovascular events, and mortality.

Conditions

Acute Kidney Injury

Keywords

Chronic kidney disease; Acute kidney disease

Outcome Measures

Primary Outcomes (2)

• Renal replacement therapy at any time after dialysis

  Patients will followed up at any time after dialysis.

  MAKE at 180 days

• survival

  Patients will followed up at any time after death.

  MAKE at 180 days

Secondary Outcomes (1)

• Rehospitalization

  MAKE at 180 days

Study Arms (2)

never received RAAS blockers or multidiscipline consultation before AKI.

ACTIVE COMPARATOR

The enrollees assigned to the control group should not receive RAAS blockers or AKD consultation at least in 180 days after index discharge. In addition, these multidiscipline consultation and administration of RAAS blockers are continuing, and results regarding them remain masked. All patients provided written informed consent.

Drug: never received RAAS blockers or received RAAS blockers before AKI.

had received RAAS blockers and multidiscipline consultation before AKI.

ACTIVE COMPARATOR

All enrolled patients are randomly referred to receive comprehensive multidiscipline consultation targeting a glycated hemoglobin level of less than 7.0%, systolic blood-pressure, target, \<130 mm Hg, low density lipid (LDL) less than 100mg/dL and control of hyperuricemia less than 7.2mg/deal in male as well as 6.1mg/dl in females. We suggest to adherence to low protein diet achieve the goal of hemoglobin more than 11g/L at 180 day after index discharge. Enrollees who are not received renin-angiotensin-aldosterone blockers (RAAS) are randomly assigned to slow kidney function progression by adding RAAS blockers by receiving at least defined daily dose equal to Losartan 50mg or Captopril 25mg bid. The acute kidney disease (AKD) consultation should be transferred at least one time within 90 days after index hospital discharge after withdrawing from dialysis requiring AKI (AKI-D).

Drug: never received RAAS blockers or received RAAS blockers before AKI.

Interventions

never received RAAS blockers or received RAAS blockers before AKI. DRUG

Enrollees who are not received renin-angiotensin-aldosterone blockers (RAAS) are randomly assigned to slow kidney function progression by adding RAAS blockers by receiving at least defined daily dose equal to Losartan 50mg or Captopril 25mg bid. The acute kidney disease (AKD) consultation should be transferred at least one time within 90 days after index hospital discharge after withdrawing from dialysis requiring AKI (AKI-D). All enrolled patients are randomly referred to receive comprehensive multidiscipline consultation targeting a glycated hemoglobin level of less than 7.0%, systolic blood-pressure, target, \<130 mm Hg, low density lipid (LDL) less than 100mg/dL and control of hyperuricemia less than 7.2mg/deal in male as well as 6.1mg/dl in females. We suggest to adherence to low protein diet achieve the goal of hemoglobin more than 11g/L at 180 day after index discharge.

Also known as: Multidiscipline consultation

had received RAAS blockers and multidiscipline consultation before AKI.; never received RAAS blockers or multidiscipline consultation before AKI.

Eligibility Criteria

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

You may qualify if:

• Age ≥ 20 years old on the day of index discharge
• AKI develops during admission, as defined with KDIGO-AKI Guideline, namely, elevation of serum creatinine above 0.3mg/dL within two days, above 1.5 times baseline and ever receives dialysis during this index hospitalization.
• Patients who has KDIGO-AKI stage 2, 3 or who could wean from dialysis requiring AKI-D in the index hospitalization.

You may not qualify if:

• Baseline estimated glomerular filtration rates (eGFR) less than 5ml/min/1.73m2 or greater than 90ml/min/1.73m2 according to MDRD equation after index discharge.
• Patients receive further re-dialysis within 90 days after index hospital discharge, who are withdrawal for AKI-D. (sensors)
• Previous gastrointestinal operations.
• Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.
• Patients with a chronic lung disease requiring non-invasive or invasive positive pressure ventilation.
• Solid organ or hematological transplantation donors.
• Evidence of obstructive acute kidney injury.
• Systolic blood pressure \< 110mmHg.
• Pregnant women

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Chang Gung Memorial Hospital: collaborator

Study Sites (7)

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

NOT YET RECRUITING

Keelung CGMH

Keelung, Taiwan

RECRUITING

China Medical University Hospital

Taichung, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vincent Wu, doctor

  NTUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Wu, doctor

CONTACT

886-937-223-278; dr.vincentwu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The randomization procedure was developed at the WHI Clinical Coordinating Center and implemented locally through a distributed study database, using a randomized permuted block algorithm, stratified by clinical center site, diabetics mellitus and age group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The randomization procedure was developed at the WHI Clinical Coordinating Center and implemented locally through a distributed study database, using a randomized permuted block algorithm, stratified by clinical center site, diabetics mellitus and age group.

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: October 1, 2021
• Study Start: February 15, 2019
• Primary Completion: January 6, 2024
• Study Completion: February 15, 2024
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

TW (7)