Risk Factors and Outcomes of Acute Kidney Injury in Patie... | NCT05867797

Studies
Risk Factors and Outcomes of Acute Kidney Injury in Patients With Diabetic Ketoacidosis at Sohag University Hospital.

NCT05867797

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

May 22, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Diabetic Ketoacidosis
Acute Kidney Injury

Interventions

Not provided

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

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2023Estimated

Primary Completion Date

May 20, 2024Estimated

Completion Date

Nov 20, 2024Estimated

First Submitted Date

May 10, 2023

First Submission Date that Met QC Criteria

May 18, 2023

First Posted Date

May 22, 2023Actual

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

May 18, 2023

Last Update Posted Date

May 22, 2023Actual

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

Diabetic ketoacidosis (DKA), a severe complication of diabetes mellitus (DM), is the leading cause of hospitalization, morbidity and mortality in patients with DM (1).

DKA is associated with hyperglycemic crises and featured by metabolic acidosis, the production of ketoacids, volume depletion, and electrolyte imbalance. Due to glucose-induced osmotic polyuria and even emesis, volume depletion is a major cause of acute kidney injury (AKI) in DKA patients (2).

Detailed Description

Not provided

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

Retention

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prognosis risk factors and outcomes of AKI in patients with DKA	complete resolution or progress to CKD or mortality and discover risk factors for AKI as uncontrolled diabetes infection or high uric acid uncontrolled hyperlipidemia	1 YEAR

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients will be included in this study aged >18 years old after diagnosis of AKI on top of Diabetic ketoacidosis at Sohag university hospital for all patients admitted during the period from May 2023 to May 2024

Exclusion Criteria:

Chronic kidney disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Diabetic ketoacidosis at Sohag university hospital for all patients admitted during the period from May 2023 to May 2024

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
zahraa Abdeaal Ahmed	Contact	01028201984		Zahraa.abdalah@med.sohag.edu.eg

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016883	Diabetic Ketoacidosis
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D007662	Ketosis
D000138	Acidosis
D000137	Acid-Base Imbalance
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided