AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Other: Clinical Recommendations

• Registration Number: NCT03236103
• Lead Sponsor: Mayo Clinic

Brief Summary

The investigators are doing this research to investigate whether multifaceted preventive measures for newly hospitalized ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence rate, progression and associated complications

Detailed Description

The purpose of the study is to investigate whether preventive measures for newly hospitalized ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence rate, progression and associated complications

Participants will be in the study for the first 7 days of hospitalization. The study investigators will access the electronic medical record daily from admission day 1 through admission day 7 in order to provide clinical recommendations in an effort to minimize AKI risk as per routine practice.

If the patient is discharged prior to day 7 the study, intervention will be terminated on day of discharge.

The investigators will review the participant's medical record up to one year after surgery.

This study will not include any experimental laboratory tests or experimental medication.

The clinical recommendations will regard the following:

1. Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast, nephrotoxic antimicrobials)

2. Optimizing volume status (avoidance of volume overload or depletion)

3. Optimizing electrolytes and acid-base status

4. Optimizing hemodynamics (Mean arterial BP\>65mmHg)

5. Assessment of kidney function with serum creatinine and/or cystatin C None of the suggestions will be experimental. All suggestions will be based on standard nephrology practice.

The investigators plan to compare the results of the current study with those in in the years of 2012-2017 (1/7/2012- 1/7/2017) via retrospective chart review

Study Timeline

• Study Start: 2017-05-19
• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-01
• Primary Completion: 2019-04-08
• Study Completion: 2019-04-08
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with VAD in place	Clinical Recommendations	Adult patients with VAD in place who are admitted to the hospital for acute medical illness. The investigators will provide clinical recommendations to the subject's primary care provider.

Primary Outcome Measures

Name	Time	Method
Rate of AKI in hospitalized VAD patients based on AKIN criteria	The first 7 days of hospitalization	The AKIN staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0 fold from baseline, OR urine output \<0.5 ml/kg/h for 6 h; 2) serum creatinine increase \> 2.0-3.0 fold from baseline OR urine output \<0.5 ml/kg/h for 12 h; 3) serum creatinine increase \>3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output \<0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT
Severity of AKI based on AKIN stages (I, II, III) 1	The first 7 days of the hospitalization	The AKIN staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0 fold from baseline, OR urine output \<0.5 ml/kg/h for 6 h; 2) serum creatinine increase \> 2.0-3.0 fold from baseline OR urine output \<0.5 ml/kg/h for 12 h; 3) serum creatinine increase \>3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output \<0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT

Secondary Outcome Measures

Name	Time	Method
In hospital, 60 day and one-year mortality	One year after enrollment	The number of subjects who died during hospitalization, 60 days after hospitalization and one year after hospitalization
Length of hospital stay	One year after hospitalization	The length of hospital stay will be determined from the electronic medical record.

Trial Locations

Locations (3)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States