NCT04962412

Brief Summary

The aim of this study was to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,152

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Longer than P75 for all trials

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

Study Start

First participant enrolled

May 12, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

September 5, 2025

Status Verified

June 1, 2025

Enrollment Period

3.6 years

First QC Date

July 4, 2021

Last Update Submit

August 29, 2025

Conditions

Acute Kidney InjuryCritical Illness

Keywords

Acute kidney injuryBiomarkerAKI progressionPoor outcomeFurosemide Stress Test

Outcome Measures

Primary Outcomes (1)

  • AKI progression

    worsening of KDIGO stage within 1 week (progressing from stage 1 to either stage 2 or stage 3, or from stage 2 to stage 3). Patients diagnosed with progressive or persisting stage 3 AKI (stage 3 AKI for \>3 consecutive days) were classified as having AKI progression. If patients who presented with stage 3 AKI but not requiring RRT subsequently required dialysis or developing persist severe AKI or death within 7 days, this was considered progression.

    7 days

Secondary Outcomes (10)

  • Mortality

    365 days

  • Receipt of renal replacement treatment

    365 days

  • Major adverse kidney events

    365 days

  • Persistent AKI

    90 days

  • Persist severe AKI

    90 days

  • +5 more secondary outcomes

Interventions

Standard care "bundle"OTHER

The management for AKI patients were performed by implementing a standard care "bundle" suggested by the Kidney Disease Improving Global Outcome (KDIGO) guideline.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42%. CSA-AKI is the second most common cause of AKI in the intensive care setting (after sepsis) and is independently associated with increased morbidity and mortality. Patients was diagnosed AKI by KDIGO criteria.

You may qualify if:

  • Patients undergoing cardiac surgery were prospectively screened, and those who developed AKI within 48 hours post-surgery were included in the study.

You may not qualify if:

  • History of End Stage Renal Disease or on Dialysis;
  • prior kidney transplantation;
  • patients with a DNR order;
  • patients without written informed consent;
  • pregnancy;
  • moribund patients with expected death within 24 h or whose survival to 28 days was unlikely due to an uncontrollable comorbidity (i.e., end-stage liver or heart disease, untreatable malignancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan hospital, Fudan university

Shanghai, 200030, China

Location

Related Publications (1)

  • Su Y, Liu WJ, Zhao YF, Zhang YJ, Qiu Y, Lu ZH, Wang P, Lin S, Tu GW, Luo Z. Modified furosemide responsiveness index and biomarkers for AKI progression and prognosis: a prospective observational study. Ann Intensive Care. 2024 Oct 8;14(1):156. doi: 10.1186/s13613-024-01387-y.

    PMID: 39379672DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serial blood and urine samples for biomarker analysis were collected after surgery and then every 6 h in day 1 and then daily until discharge from ICU or for a maximum of 7 days, respectively. Plasma (EDTA), serum, and urine supernatants were frozen within 2 h of sample collection, stored at -80℃, and thawed immediately before analysis.

MeSH Terms

Conditions

Acute Kidney InjuryCritical Illness

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zhe Luo, Professor

    Fudan University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
365 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Scientific Secretary for Department of Critical Care Medcine

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 15, 2021

Study Start

May 12, 2021

Primary Completion

December 31, 2024

Study Completion

May 31, 2025

Last Updated

September 5, 2025

Record last verified: 2025-06

Locations

CN(1)