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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236103
• Other study ID #: 17-002670
• Status: Completed
• Phase: N/A
• Start date: May 19, 2017
• Est. completion date: April 8, 2019

Study information

• Verified date: October 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: April 8, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• Clinical Recommendations
The clinical recommendations will regard the following: Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast, nephrotoxic antimicrobials) Optimizing volume status (avoidance of volume overload or depletion) Optimizing electrolytes and acid-base status Optimizing hemodynamics (Mean arterial BP>65mmHg) 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Length of hospital stay	The length of hospital stay will be determined from the electronic medical record.	One year after hospitalization
Secondary	In hospital, 60 day and one-year mortality	The number of subjects who died during hospitalization, 60 days after hospitalization and one year after hospitalization	One year after enrollment

External Links

•   Mayo Clinic Clinical Trials