NCT03486184

Brief Summary

Postoperative Acute Kidney Injury in Patients Undergoing Prolonged Neurosurgical Operations

Trial Health

35
At Risk

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 May 2018

Status
unknown

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

March 22, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

March 22, 2018

Last Update Submit

March 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • the occurrence of AKI

    BY using AKIN criteria.

    2 days

Interventions

Cystatin-CDIAGNOSTIC_TEST

* Laboratory values will be obtained, including level of preoperative serum creatinine, complete blood count, coagulation profile and Cystatin-C (5 ml. venous sample). * Serum creatinine and hemoglobin will be measured after operation, and thereafter at least once a day as a part of routine clinical care. Postoperative serum Cystatin-C will measured only once.

Eligibility Criteria

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

patients aged 18 years or older

You may qualify if:

  • patients aged 18 years or older who will do prolonged neurosurgical procedure, duration of surgery more than 4 hours and ASA 1-2-3.

You may not qualify if:

  • refusal of consent, preexisting renal transplantation, preexisting nephrectomy, presence of AKI before neurosurgical procedure, operation less than 4 hours, patients aged under 18 years, pregnancy and ASA 4-5.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Deng Y, Yuan J, Chi R, Ye H, Zhou D, Wang S, Mai C, Nie Z, Wang L, Zhai Y, Gao L, Zhang D, Hu L, Deng Y, Chen C. The Incidence, Risk Factors and Outcomes of Postoperative Acute Kidney Injury in Neurosurgical Critically Ill Patients. Sci Rep. 2017 Jun 26;7(1):4245. doi: 10.1038/s41598-017-04627-3.

    PMID: 28652590BACKGROUND

Central Study Contacts

Ali M Abdel-Salam, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

March 22, 2018

First Posted

April 3, 2018

Study Start

May 1, 2018

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

April 3, 2018

Record last verified: 2018-03