MedDataX Logo

Preventing Acute Kidney Injury

NCT ID: NCT04376619

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Acute kidney injury increases the risk for chronic kidney disease, length of stay, readmissions and mortality. Currently the only way to diagnose acute kidney injury is with a serum creatinine or drop in urine output. Biomarkers for acute kidney injury are well elevated before rise in creatinine. Hypothesis is that by implementing an electronic alert system with an algorithm followed by remote ischemic preconditioning will prevent acute kidney injury.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The propose study is to incorporate an alert system in current medical health system and an algorithm will be used to activate clinicians and Nephrologist to confirm if patient is at high risk. Once identified as high risk the clinician and/or nephrologist will intervene and change current management if needed. First phase of study will look at an alert system and algorithm was enough to lower incidence of acute kidney injury. Phase 2 will also use alert system and algorithm that will be further randomized those that are identified as high risk for acute kidney injury to remote ischemic preconditioning.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Kidney Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Two part study: all patients will be triaged by alert system whether they are high risk for acute kidney injury and those patients that are identified as high risk for AKI have standard of care implemented by following kidney disease improving global outcomes guidelines in preventing AKI and part 2 will perform procedure called remote ischemic preconditioning in addition to standard of care in part1 in those patients that are identified as high risk for acute kidney injury.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

KDIGO guidelines

Part 1 of study, those identified as high risk for AKI then will have Kidney Disease Global Improving outcomes guideline implemented to see if this reduces incidence of AKI

Group Type EXPERIMENTAL

KDIGO guidelines

Intervention Type OTHER

KDIGO stands for Kidney disease Improving global outcomes guidelines, and have guidelines for prevention and treatment of AKI which is considered standard of care.

RIPC

part 2 of study, those identified as high risk of AKI will have Kidney Disease Improving Global Outcomes guidelines and RIPC implemented to see if this reduces incidence of AKI compared to part 2 of study

Group Type EXPERIMENTAL

remote ischemic preconditioning

Intervention Type OTHER

inflation and deflation of cuff 5min each cycle repeated 3 times

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

remote ischemic preconditioning

inflation and deflation of cuff 5min each cycle repeated 3 times

Intervention Type OTHER

KDIGO guidelines

KDIGO stands for Kidney disease Improving global outcomes guidelines, and have guidelines for prevention and treatment of AKI which is considered standard of care.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* Patients who's creatinine returns to baseline after admitted can be included in study if patient still remains admitted.


* End stage renal disease
* estimated glomerular filtration rate less then 20
* Left ventricular assist device patients
* observation status
* hospice patients
* pregnancy
* age less then 18
* acute kidney injury on admission defined as 1.5 times elevated creatinine prior to last admission's creatinine
* nephrology consult already placed
* renal transplant or nephrectomy within 1 year
* Patients unable to provide consent

exclusion for remote ischemic preconditioning in addition to above exclusion will be:

* symptoms or diagnosis of peripheral arterial disease
* Patients in shock defined by requiring inotropes or vasopressors
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Atlantic Health System

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shivangi K. Patel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shivangi Patel, M.D.

Role: PRINCIPAL_INVESTIGATOR

atlantich health system

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1527104-1

Identifier Type: -

Identifier Source: org_study_id