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

NCT03236103 | Completed

• 1 other identifier: 17-002670
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 3

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

Conditions

Acute Kidney Injury

Keywords

Ventricular assist device

Outcome Measures

Primary Outcomes (2)

• Rate of AKI in hospitalized VAD patients based on AKIN criteria

  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

  The first 7 days of hospitalization

• Severity of AKI based on AKIN stages (I, II, III) 1

  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

  The first 7 days of the hospitalization

Secondary Outcomes (2)

• Length of hospital stay

  One year after hospitalization

• In hospital, 60 day and one-year mortality

  One year after enrollment

Study Arms (1)

Subjects with VAD in place

OTHER

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.

Other: Clinical Recommendations

Interventions

Clinical Recommendations OTHER

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.

Subjects with VAD in place

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with VAD in place who are admitted to the hospital for acute medical illness during the study period. For those with multiple admissions during the study period only the first admission will be studied.
• Patients who are able to give consent. In case of patients that are mentally impaired we will obtain consent from power of attorney and when patients regain intact mental capacity we will reobtain consent from the patient.

You may not qualify if:

• Patients on dialysis (hemodialysis or peritoneal dialysis).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

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

• Qi Qian

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Open label single group interventional study

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 1, 2017
• Study Start: May 19, 2017
• Primary Completion: April 8, 2019
• Study Completion: April 8, 2019
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

US (3)