Short-term Atorvastatin's Effect on Acute Kidney Injury Following Cardiac Surgery

NCT00791648 | Completed Results DMC

• 1 other identifier: 081238
• Study Type: interventional
• Target: 653
• Locations: 1 country
• Sites: 1

Brief Summary

Aim1a: Statin naive patient's scheduled for cardiac surgery will be randomized to 80mg atorvastatin or placebo on the day prior to surgery and then 40mg daily thereafter until hospital discharge to test the hypothesis that short-term atorvastatin use decreases:

1. 1.acute kidney injury following cardiac surgery.
2. 2.postoperative delirium following cardiac surgery.
3. 3.acute kidney injury following cardiac surgery.
4. 4.postoperative delirium following cardiac surgery.

Conditions

Acute Kidney Injury; Post-Operative Delirium; Icu Delirium; Acute Renal Failure; Delirium

Keywords

aki; delirium; statin; short-term; cardiac

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Acute Kidney Injury

  postoperative day 2

• Number of Participants With Delirium

  while in ICU (about 2 days)

Secondary Outcomes (14)

• Number of Participants Requiring Dialysis

  while in ICU (about 2 days)

• Liver Enzyme: Aspartate Aminotransferase Level

  postoperative day 1

• Number of Participants With Stroke

  while in ICU (about 2 days)

• Number of Participants That Died

  until postoperative hospital discharge (about 7 days)

• Mitochondrial Function--mtDNA Copy Number

  anesthesia induction and POD 1

Study Arms (2)

statin

EXPERIMENTAL

Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge. Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.

Drug: atorvastatin

placebo

PLACEBO COMPARATOR

Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge. Aim 2 control: placebo the day of cardiac surgery and postop day 1.

Drug: placebo

Interventions

atorvastatin DRUG

Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge. Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.

Also known as: Lipitor

statin

placebo DRUG

Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge. Aim 2 control: placebo the day of cardiac surgery and postop day 1.

placebo

Eligibility Criteria

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

You may qualify if:

• open heart surgery

You may not qualify if:

• acute coronary syndrome with troponin leak or unrelenting angina
• liver dysfunction (transaminases 2x normal)
• history of myopathy or liver dysfunction on prior statin therapy
• use of potent CYP3A4 inhibitors such as antifungal azoles, macrolide antibiotics, HIV protease inhibitors, and nefazodone.
• pregnancy or breast feeding
• cyclosporine use
• dialysis
• history of kidney transplant
• fibrate users who cannot stop fibrate use.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (3)

• Smith LE, Smith DK, Blume JD, Linton MF, Billings FT 4th. High-Density Lipoprotein Cholesterol Concentration and Acute Kidney Injury After Cardiac Surgery. J Am Heart Assoc. 2017 Dec 9;6(12):e006975. doi: 10.1161/JAHA.117.006975.

  PMID: 29223955 DERIVED

• Billings FT 4th, Hendricks PA, Schildcrout JS, Shi Y, Petracek MR, Byrne JG, Brown NJ. High-Dose Perioperative Atorvastatin and Acute Kidney Injury Following Cardiac Surgery: A Randomized Clinical Trial. JAMA. 2016 Mar 1;315(9):877-88. doi: 10.1001/jama.2016.0548.

  PMID: 26906014 DERIVED

• Billings FT 4th, Ball SK, Roberts LJ 2nd, Pretorius M. Postoperative acute kidney injury is associated with hemoglobinemia and an enhanced oxidative stress response. Free Radic Biol Med. 2011 Jun 1;50(11):1480-7. doi: 10.1016/j.freeradbiomed.2011.02.011. Epub 2011 Feb 18.

  PMID: 21334433 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Emergence Delirium; Delirium

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Frederic Billings
• Organization: Vanderbilt University

frederic.t.billings@vanderbilt.edu

615-343-6268

Study Officials

• Frederic T. Billings, IV, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 14, 2008
• Study Start: July 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 16, 2019
• Results First Posted: March 6, 2017

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available within 6 weeks of request and will be available indefinitely.
• Access Criteria: These data will be made available upon reasonable request.

Locations

US (1)