Improving Post Discharge Care After Acute Kidney Injury

NCT02915575 | Completed

• 1 other identifier: Pro00067815
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this trial is to test the clinical benefit and feasibility of structured risk based post discharge care for hospital acquired Acute kidney injury survivors.This is a Pragmatic randomized controlled trial. It will be conducted at 2 hospitals in Alberta. 166 participants will be enrolled in this Randomized controlled trial..

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Proportion of patients develop Chronic kidney disease after Acute kidney injury

  The primary (process based) outcome of this trial is the proportion of patients with CKD meeting all three quality of care indicators (statin use, ACEi/ARB use in those with proteinuria (ACR\>30mg/mmol) or diabetes, nephrologist visit if sustained eGFR\<30ml/min/1.73m2) within 90 days of hospital

  90 days

Secondary Outcomes (4)

• Proportion of patients completed the lab and seen by PCP

  90 days

• check eGFR

  one year

• Hospitalization

  one year

• Feasibility

  one year

Study Arms (2)

Control Arm (usual care)

OTHER

Participants will be discharged as per usual ward discharge protocols.

Other: Usual Care

Risk guided follow-up

OTHER

Participant will be stratified for risk of CKD in three groups: Low (\<1% risk of CKD), medium (1-10 % risk of CKD) and high (≥10 % risk of CKD). Specific follow-up will be guided by risk status

Other: Risk guided follow-up

Interventions

Risk guided follow-up OTHER

Participant will be stratified for risk of CKD in three groups: Low (\<1% risk of CKD), medium (1-10 % risk of CKD) and high (≥10 % risk of CKD). Specific follow-up will be guided by risk status

Risk guided follow-up

Usual Care OTHER

Participants will be discharged as per usual ward discharge protocols.

Control Arm (usual care)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 yrs
• At least a doubling of serum creatinine during hospitalization (including need for dialysis)
• Have a primary care physician (PCP)
• No nephrologist follow up arranged after hospital discharge

You may not qualify if:

• Baseline GFR\<30ml/min/1.73m2(CKD-EPI) or requiring chronic dialysis on admission
• Renal transplant recipients
• Poor prognosis not expected to survive \> 6 months
• Residence at a nursing home facility

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

Foothills Hospital

Calgary, Alberta, Canada

Location

University of Alberta hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Neesh Pannu, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Matthew James, MD

  Foothills Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 27, 2016
• Study Start: March 19, 2018
• Primary Completion: December 31, 2023
• Study Completion: November 30, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)