NCT06156098

Brief Summary

Exploring the predictive and evaluative value of various indicators of bedside critical renal ultrasound in critically ill patients with acute kidney injury (AKI)

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

October 6, 2023

Last Update Submit

April 8, 2024

Conditions

Critical Illness

Keywords

Critical IllnessUltrasound TherapyKidney injury

Outcome Measures

Primary Outcomes (1)

  • Survival

    28-day mortality rate

    28 days

Secondary Outcomes (1)

  • AKI

    28 days

Interventions

No InterventionOTHER

No Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Criteria for sepsis patients: Clear infection focus, Sequential Organ Failure Assessment (SOFA) score ≥ 2. Criteria for septic shock patients: Despite active fluid resuscitation, patients still require vasoactive drugs to maintain blood pressure, with arterial blood lactate level ≥ 2mmol/L. Other critically ill patients include those with shock of various causes,

You may qualify if:

  • Age ≥ 18 years and ≤ 70 years
  • Criteria for sepsis patients

You may not qualify if:

  • Pregnant women.
  • Patients with malignant tumors, severe heart failure, chronic renal insufficiency, end stage renal disease, kidney transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Qin Zhang, phd

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Zhang, phd

CONTACT

15926207366ranxiao1001@tjh.tjmu.edu.cn

Qin Zhang, phd

CONTACT

15717154768qzhang8@tjh.tjmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2023

First Posted

December 5, 2023

Study Start

September 1, 2023

Primary Completion

November 30, 2023

Study Completion

September 30, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

CN(1)