Clinical trial NCT03236103: AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.
Official title: AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Ventricular assist device
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label single group interventional study
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion criteria:

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.

Exclusion criteria:

Patients on dialysis (hemodialysis or peritoneal dialysis).

Primary outcomes:
measure: Rate of AKI in hospitalized VAD patients based on AKIN criteria
timeFrame: The first 7 days of hospitalization
measure: Severity of AKI based on AKIN stages (I, II, III) 1
timeFrame: The first 7 days of the hospitalization
Secondary outcomes:
measure: Length of hospital stay
timeFrame: One year after hospitalization
measure: In hospital, 60 day and one-year mortality
timeFrame: One year after enrollment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Qi Qian
role: PRINCIPAL_INVESTIGATOR
References: