Reguired field in Acute Kidney Injury - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Acute Kidney Injury

Intervention / Treatment

Other: Reguired field

Detailed Description

Assiut Medical School Research Proposal Form 2 Part 2: Research Details 2.1 Background (Research Question, Available Data from the literature, Current strategy for dealing with the problem, Rationale of the research that paves the way to the aim(s) of the work).

Numerous studies have evaluated the prevalence and importance of mineral and bone disorders among patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). However, little is known about dysregulated mineral and bone metabolism in acute kidney injury (AKI) [ Acute kidney injury is the new consensus term for acute renal failure It refers to a clinical syndrome characterised by a rapid (hours to days) decrease in renal excretory function, with the accumulation of products of nitrogen metabolism such as creatinine and urea and other clinically unmeasured waste products. Other common clinical and laboratory manifestations include decreased urine output (not always present), accumulation of metabolic acids, and increased potassium and phosphate concentrations. The term acute kidney injury has replaced acute renal failure to emphasise that a continuum of kidney injury exists that begins long before sufficient loss of excretory kidney function can be measured with standard laboratory tests. The term also suggests a continuum of prognosis, with increasing mortality associated with even small rises in serum creatinine, and additional increases in mortality as creatinine concentration rises. The incidence of acute kidney injury (AKI) is increasing among hospitalized patients . Treating the condition consumes significant amounts of resources even after hospital discharge

. Although AKI was once considered a reversible condition, mounting evidence has indicated that AKI may have a negative impact upon subsequent renal function and long-term prognosis, even if kidney

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Asmaa Mohmed, طبيب مقيم
Phone Number: 01113808804
Email: Asmaaahmed17994@yahoo.com

Study Contact Backup

Name: Dr Esam abd elaziz Abdel aziz
Phone Number: ‪0100 969 9081‬
Email: Essam.nephro@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

c. Sample Size Calculation: 200 cases , 200 controls from December 2021to December 2023 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):

Study techniques:

a) Full (thorough) history & clinical examination. b) Laboratory investigations:

Blood Urea, Serum creatinine
Pth
Ph
Ca
Na
k
Mg
Vit d
Other routine investigations c) Imaging:
Abdominal U/S d) ECG 2.4.5 -Research outcome measures:
a. Primary (main):
Identify the association between Acut

Description

Inclusion Criteria:

200 patients with acute kidney injury and their relationship to mineral bone disease.

Exclusion Criteria:

Non hypertensive
Non cardiac
Active malignancy
Acute or chronic liver disease
Acute poisoning
Covid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relation between AKI and mineral bone disease Time Frame: Baseline	Relationship between acute kidney injury and mineral bone disease	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 25, 2022

Primary Completion (Anticipated)

September 25, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

September 11, 2022

First Submitted That Met QC Criteria

September 19, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)