NCT03097393

Brief Summary

The aim of this study is to examine if procalcitonin (PCT) can be used for early prediction of AKI septic patients in ICU.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

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, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

3.2 years

First QC Date

March 25, 2017

Last Update Submit

March 25, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • development of AKI

    elevated kidney functions creatinine or oliguria

    28 Days

Study Arms (2)

AKI GROUP

measure Procalcitonin among Patient developed Acute kidney injury during ICU stay

Diagnostic Test: measure Serum procalcitonin level

Non-AKI group

measure Procalcitonin among Patient did not develop Acute kidney injury during ICU stay

Diagnostic Test: measure Serum procalcitonin level

Interventions

measuring procalcitonin level

AKI GROUPNon-AKI group

Eligibility Criteria

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

ICU patients with sepsis

You may qualify if:

  • ICU patients with sepsis

You may not qualify if:

  • Patient known to have End-stage kidney disease
  • Patients on Renal replacement therapy
  • patients without procalcitonin level within 24 hours from admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Internal Medidicne Department- Faculty of Medicine

Study Record Dates

First Submitted

March 25, 2017

First Posted

March 31, 2017

Study Start

January 1, 2014

Primary Completion

February 28, 2017

Study Completion

March 1, 2017

Last Updated

March 31, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share