AKI Prevention and Early Intervention in Patients Undergoing VAD Placement

Kidney Injury Clinical Trial

Official title:

AKI Prevention and Early Intervention in Patients Undergoing VAD Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236831
• Other study ID #: 17-001893
• Status: Completed
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: February 17, 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 find out if more careful assessment and elimination of potential risk factors of acute kidney injury (AKI) during the subject's perioperative period will reduce their chance of kidney damage and kidney damage related problems.

Description:

The purpose of the study is to investigate whether preventive measures for patients undergoing ventricular assist device (VAD) placement will reduce AKI occurrence, progression and associated complications.

Participants will be in the study for a total of 6 days (1 day prior to the surgery and 5 days after the surgery). The investigators will review the participant's medical record up to one year after surgery.

The study investigators will access the participant's electronic medical record 24 hours prior to the planned VAD implantation and review the participant's medication regimen and provide recommendations to the participant's primary care physician in an effort to minimize potential risks for AKI. There will be no intervention during the operation.

The clinical recommendations will cover the following:

1. Avoidance of potentially nephrotoxic agents.

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

3. Optimizing electrolytes and acid-base status

4. Minimizing IV contrast exposure when appropriate

5. Treating severe anemia

6. Optimization of hemodynamics (Mean arterial BP>65mmHg).

The investigators plan to compare the results of this study with the historical data in the same patient population in the years of 7/1/2015-6/30/2017.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: February 17, 2019
• Est. primary completion date: February 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Adult patients that will undergo VAD placement.

• Patients able to give consent

Exclusion criteria:

• Patients on dialysis (hemodialysis or peritoneal dialysis)

• Non-elective VAD placement (VAD implantation decision made within 24 hours)

Related Conditions & MeSH terms

• Kidney Injury

Intervention

Other:
• Clinical Recommendations
The investigators will provide clinical recommendations to the subject's primary care provider. These will be in regards to the following: Avoidance of potentially nephrotoxic medications. Optimizing volume status (avoidance of volume overload or depletion) Optimizing electrolytes and acid-base status Minimizing IV contrast exposure when appropriate Treating severe anemia Optimization of hemodynamics (Mean arterial BP>65mmHg)

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

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 postoperative AKI (within 5 post-op days) based on AKIN criteria	The Acute Kidney Injury Network (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	5 days after the surgery
Secondary	Severity of postoperative AKI (within 5 post-op days) 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	5 days after the surgery
Secondary	Length of hospital stay	The length of hospital stay will be determined from the electronic medical record.	1 year after the surgery
Secondary	In hospital (perioperative) mortality and one-year mortality	The number of subjects who died in hospital (perioperatively) and one year after surgery	Approximately 5 days after surgery, one year after enrollment

External Links

•   Mayo Clinic Clinical Trials