NCT03789747

Brief Summary

The aim of this study was to investigate the incidence, risk factors and prognosis of acute kidney injury (AKI) in critically ill patients after craniotomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration 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

January 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2017

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

May 11, 2017

Last Update Submit

February 8, 2025

Conditions

EpidemiologyAcute Kidney InjuryRisk Factor

Keywords

incidenceprognosisacute kidney injuryrisk factorpost-craniotomy

Outcome Measures

Primary Outcomes (1)

  • Incidence and outcome of AKI after Craniotomy

    All adult patients who underwent craniotomy and admitted into intensive care unit (ICU) between January 2017 and December 2018 were screened for acute kidney injury.

    during hospitalization

Secondary Outcomes (1)

  • Risk factors for AKI after Craniotomy

    during hospitalization

Interventions

As a observational study, there is no intervention.OTHER

As a observational study, there is no intervention.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who underwent craniocerebral operation and admitted into intensive care unit (ICU) between January 2017 and December 2018 were consecutively screened. Patients developed AKI after ICU admission were deemed as cases, and those without AKI were included in the control group.

You may qualify if:

  • patients underwent craniotomy
  • admitted into ICU ward and the ICU length of stay ≥24h

You may not qualify if:

  • Age\< 18 years;
  • Patients with pre-existing acute kidney injury (AKI) and chronic kidney disease undergoing long-term renal replacement therapy (RRT) .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tian Tan hospital

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jianxin Zhou, MD

    Beijing Tian Tan Hospital

    STUDY DIRECTOR

  • Guangzhi Shi, MD

    Beijing Tian Tan Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 11, 2017

First Posted

December 31, 2018

Study Start

January 1, 2017

Primary Completion

December 31, 2018

Study Completion

April 30, 2020

Last Updated

February 11, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)