Standard Versus Comprehensive Care for Post Acute Kidney Injury

Standard Versus Comprehensive Care for Post Acute Kidney Injury: A Randomized Controlled Trial

The investigators aim to compare between standard versus comprehensive care for post-acute kidney injury who are admitted with acute kidney injury at least stage 2 or receive renal replacement therapy.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: Standard care; Other: Comprehensive care

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Acute kidney injury at least stage 2 OR
• Received renal replacement therapy

Exclusion Criteria:

• Post kidney transplantation
• End-stage renal disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care; Regular follow-up by internists every 3 month; May consult nephrologists case-by-case	Other: Standard care; Regular follow-up by internists every 3 month; May consult nephrologists case-by-case
Experimental: Comprehensive care; Regular follow-up by nephrologists every 1-3 month; Multidisciplinary team consisting pharmacists, nurses, and dieticians	Other: Comprehensive care; Regular follow-up by nephrologists every 1-3 month; Multidisciplinary team consisting pharmacists, nurses, and dieticians

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1 year major adverse kidney events	1-year

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Publications and helpful links

General Publications

• Thanapongsatorn P, Chaikomon K, Lumlertgul N, Yimsangyad K, Leewongworasingh A, Kulvichit W, Sirivongrangson P, Peerapornratana S, Chaijamorn W, Avihingsanon Y, Srisawat N. Comprehensive versus standard care in post-severe acute kidney injury survivors, a randomized controlled trial. Crit Care. 2021 Aug 31;25(1):322. doi: 10.1186/s13054-021-03747-7.

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2019
• Primary Completion (Actual): July 16, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: IRB.005/62

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No