Multidiscipline Care for Acute Kidney Disease (AKD)

NCT ID: NCT05064904

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2024-02-15

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.

Detailed Description

In the past decade, acute kidney injury (AKI) has emerged as a syndrome of increasing prevalence. Since 2005, hospital-diagnosed cases of AKI have outnumbered those of chronic kidney disease (CKD), and this trend has continued to climb. Patients diagnosed with AKI are at risk for a variety of adverse outcomes, including premature death, morbidity, prolonged hospitalization, and increased medical costs. Potential contributing factors to the development of AKI include pre-existing kidney damage, hemodynamic instability, and the complexity of concurrent medications. As modern medical diagnostic and treatment tools have advanced, the incidence and prevalence of AKI have been steadily rising.

The KDIGO Guideline for AKI recommended that we should diagnose AKI if a given patient has a 6 hour urine amount less than 0.5ml/kg/hr or a serum creatinine elevates more than 0.3mg/dL or 1.5 times greater than baselines. Epidemiology data on hospitalized patients indeed disclosed high risk for adverse events using this classification system and its analogues. However, besides diagnosis, we do not have a useful tool to treat or to help improve patient outcomes Acute kidney injury (AKI) is a common complication that affects nearly 5% of hospitalized patients and 40%-70% of patients in the intensive care unit. AKI requiring dialysis (AKI-D), the most severe type of AKI, is associated with the highest proportion of morbidity and mortality. AKI is associated with a risk of end-stage renal disease (ESRD) that is 13 times as high as the risk among patients without AKI, and the risk of ESRD is 40 times as high if the patients have both AKI and pre-existing chronic kidney disease (CKD). Since AKI is recognized as a risk factor for the development of ESRD, it is crucial to have appropriate protection strategies for the avoidance of further target organ damage and associated mortality in the critical phases of the acute kidney disease (AKD). Patients with Acute Kidney Injury (AKI) requiring dialysis (AKI-D) are associated with the highest proportion of morbidity and mortality. AKI is associated with a thirteen-fold higher risk of end-stage renal disease (ESRD) compared to those without AKI, and a forty-fold higher risk if the patient has both AKI and pre-existing chronic kidney disease (CKD). Given the potential for AKI to lead to ESRD, it is essential to develop strategies to protect the target organs from further damage and associated mortality during the acute phase of AKD. Guyton proposed that the kidneys have a crucial role in determining the chronic level of blood pressure (BP), and studies have validated this hypothesis. Furthermore, hospitalization-associated AKI has been identified as an independent risk factor for the development of elevated BP. Elevated BP is a leading risk factor for global health and cardiovascular disease, making it a key element in the pharmacologic treatment and long-term protection of AKD patients. A retrospective analysis of the ICU database, which included 1551 ICU survivors, 611 of which had AKI during their stay, demonstrated a reduced 1-year mortality in those who had AKI and had been prescribed ACEIs/ARBs.

To address the gap between acute kidney injury (AKI) and chronic kidney disease (CKD), the Kidney Disease: Improving Global Outcomes (KDIGO) AKI Workgroup has proposed the concept of acute kidney disease (AKD). AKD is defined as a glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m2 or evidence of structural kidney damage that has been present for less than 3 months. This concept provides an integrated bridge between AKI and CKD and also emphasizes the concept of partial renal recovery. It may help to raise awareness and create the necessary clinical mechanisms to follow up AKI survivors for the potential progression to CKD, which has been recently highlighted as a missed opportunity for adequate transitions of care. Furthermore, a panel of gut microbiota and biomarkers will be determined.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

never received RAAS blockers or multidiscipline consultation before AKI.

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.

Group Type: ACTIVE_COMPARATOR

never received RAAS blockers or received RAAS blockers before AKI.

Intervention Type: 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.

had received RAAS blockers and multidiscipline consultation before AKI.

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).

Group Type: ACTIVE_COMPARATOR

never received RAAS blockers or received RAAS blockers before AKI.

Intervention Type: 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.

Interventions

never received RAAS blockers or received RAAS blockers before AKI.

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.

Intervention Type: DRUG

Other Intervention Names

Multidiscipline consultation

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 20 years old on the day of index discharge

2. 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.

3. Patients who has KDIGO-AKI stage 2, 3 or who could wean from dialysis requiring AKI-D in the index hospitalization.

Exclusion Criteria

1. 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.

2. Patients receive further re-dialysis within 90 days after index hospital discharge, who are withdrawal for AKI-D. (sensors)

3. Previous gastrointestinal operations.

4. Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.

5. Patients with a chronic lung disease requiring non-invasive or invasive positive pressure ventilation.

6. Solid organ or hematological transplantation donors.

7. Evidence of obstructive acute kidney injury.

8. Systolic blood pressure < 110mmHg.

9. Pregnant women

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Wu, doctor

Role: PRINCIPAL_INVESTIGATOR

NTUH

Locations

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status: NOT_YET_RECRUITING

Keelung CGMH

Keelung, , Taiwan

Site Status: RECRUITING

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status: RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Vincent Wu, doctor

Role: CONTACT

dr.vincentwu@gmail.com

886-937-223-278

Facility Contacts

SHANG-JHIH HUANG

Role: primary

Heng-Chih Pan

Role: primary

Ya-Fei Yang

Role: primary

Ming-Ju Wu

Role: primary

Vincent Wu, doctor

Role: primary

dr.vincentwu@gmail.com

886-937223278

Der-Cherng Tarng

Role: primary

CHIH-HSIANG CHANG

Role: primary

Other Identifiers

201900796A3C502

Identifier Type: OTHER

Identifier Source: secondary_id

201811079MINC

Identifier Type: -

Identifier Source: org_study_id