NCT04012008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

July 16, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

3 years

First QC Date

July 4, 2019

Last Update Submit

October 27, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 1 year major adverse kidney events

    1-year

Study Arms (2)

Standard care

ACTIVE COMPARATOR

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

Other: Standard care

Comprehensive care

EXPERIMENTAL

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

Other: Comprehensive care

Interventions

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

Comprehensive care

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

Standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Post kidney transplantation
  • End-stage renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn University

Bangkok, Thailand

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Comprehensive Health CareStandard of Care

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services AdministrationQuality Indicators, Health CareQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 9, 2019

Study Start

July 16, 2019

Primary Completion

July 16, 2022

Study Completion

September 30, 2022

Last Updated

October 31, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations