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Standard Versus Comprehensive Care for Post Acute Kidney Injury

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Comprehensive care
Standard care
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Post kidney transplantation
  • End-stage renal disease

Sites / Locations

  • Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care

Comprehensive care

Arm Description

Regular follow-up by internists every 3 month May consult nephrologists case-by-case

Regular follow-up by nephrologists every 1-3 month Multidisciplinary team consisting pharmacists, nurses, and dieticians

Outcomes

Primary Outcome Measures

1 year major adverse kidney events

Secondary Outcome Measures

Full Information

First Posted
July 4, 2019
Last Updated
October 27, 2022
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT04012008
Brief Title
Standard Versus Comprehensive Care for Post Acute Kidney Injury
Official Title
Standard Versus Comprehensive Care for Post Acute Kidney Injury: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
July 16, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Regular follow-up by internists every 3 month May consult nephrologists case-by-case
Arm Title
Comprehensive care
Arm Type
Experimental
Arm Description
Regular follow-up by nephrologists every 1-3 month Multidisciplinary team consisting pharmacists, nurses, and dieticians
Intervention Type
Other
Intervention Name(s)
Comprehensive care
Intervention Description
Regular follow-up by nephrologists every 1-3 month Multidisciplinary team consisting pharmacists, nurses, and dieticians
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Regular follow-up by internists every 3 month May consult nephrologists case-by-case
Primary Outcome Measure Information:
Title
1 year major adverse kidney events
Time Frame
1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute kidney injury at least stage 2 OR Received renal replacement therapy Exclusion Criteria: Post kidney transplantation End-stage renal disease
Facility Information:
Facility Name
Chulalongkorn University
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34465357
Citation
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.
Results Reference
derived

Learn more about this trial

Standard Versus Comprehensive Care for Post Acute Kidney Injury

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