Preventing Acute Kidney Injury

NCT04376619 | Withdrawn DMC

• 1 other identifier: 1527104-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• number of participants who developed acute kidney injury

  development of acute kidney injury as measured by serum creatinine 1.5 times more then baseline

  during hospitalization, up to three months

• number of participants who required dialysis

  need for initiation of dialysis after acute kidney injury develops during the admission

  during hospitalization, up to three months

Secondary Outcomes (5)

• number of participants who are placed on hospice or have expired

  at time of admission when enrolled in study to 1 year post discharge

• progression to chronic kidney disease

  at time of admission when enrolled in study to 1 year post discharge

• number of participants who receive dialysis

  at time of admission when enrolled in study to 1 year post discharge

• number of participants who are readmitted

  discharged from when enrolled in study to 1 year post discharge

• length of stay

  during hospitalization, up to three months

Study Arms (2)

KDIGO guidelines

EXPERIMENTAL

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

Other: KDIGO guidelines

RIPC

EXPERIMENTAL

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

Other: remote ischemic preconditioning

Interventions

remote ischemic preconditioning OTHER

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

RIPC

KDIGO guidelines 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.

KDIGO guidelines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• symptoms or diagnosis of peripheral arterial disease
• Patients in shock defined by requiring inotropes or vasopressors

Sponsors & Collaborators

• Atlantic Health System: lead

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Shivangi Patel, M.D.

  atlantich health system

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: May 6, 2020
• Study Start: August 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: six months at end of study and for 3 more months post study completion
• Access Criteria: must be involved in implementing /executing the study