Serum Procalcitonin Level May Predict Acute Kidney Injury... | NCT03097393

Studies
Serum Procalcitonin Level May Predict Acute Kidney Injury in ICU Patients With Sepsis

NCT03097393

Sponsor

Benha University

Status

Completed

Last Update Posted

Mar 31, 2017Actual

Enrollment

67Actual

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

measure Serum procalcitonin level

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Feb 28, 2017Actual

Completion Date

Mar 1, 2017Actual

First Submitted Date

Mar 25, 2017

First Submission Date that Met QC Criteria

Mar 25, 2017

First Posted Date

Mar 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2017

Last Update Posted Date

Mar 31, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Hamada imam, Lecturer in Internal Medidicne Department- Faculty of Medicine, Benha UniversityPrincipal Investigator

Lead Sponsor

Benha UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

67 patients with sepsis were enrolled in this study. On admission, PCT was measured together with serum creatinine, urea, and other inflammatory markers. Quick Sepsis-related Organ Failure Assessment was calculated at the emergency department. Patients were classified into those with Acute kidney injury (AKI) and non-AKI groups.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
measure Serum procalcitonin level	Diagnostic Test	measuring procalcitonin level	AKI GROUP Non-AKI group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
development of AKI	elevated kidney functions creatinine or oliguria	28 Days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ICU patients with sepsis

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ICU patients with sepsis

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided