Lithium in Acute Kidney Injury

NCT03056248 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 02116
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

A growing body of pre-clinical evidence suggests that glycogen synthase kinase 3β (GSKβ) is implicated in the development and progression of acute kidney injury (AKI). Lithium is a naturally occurring standard inhibitor of GSKβ. The purpose of this study is to examined if low dose lithium carbonate is able to reduce the incidence of AKI in patients undergoing cardiac surgery who are placed on cardiopulmonary bypass during surgery. We hypothesize that low dose lithium might reduce the incidence and duration of AKI in patients undergoing cardiac surgery who are on cardiopulmonary bypass.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Change in serum creatinine mg/dl

  Renal function

  1 month

Secondary Outcomes (3)

• Peak creatinine mg/dl

  1 month

• Neutrophil gelatinase-associated lipocalcin (NGAL) ng/ml

  3 days

• Kidney injury molecule-1 (KIM1) ng/ml

  3 days

Study Arms (2)

Lithium

ACTIVE COMPARATOR

Patients will be identified by chart review and be explained the purpose of the study and informed consent taken

Drug: Lithium Carbonate

Placebo

PLACEBO COMPARATOR

Patients will be identified by chart review and be explained the purpose of the study and informed consent taken

Drug: Placebo oral capsule

Interventions

Placebo oral capsule DRUG

On day 0, the day of the cardiac surgery placebo will be given once On day 1, one day after cardiac surgery placebo will be given once On day 2, two days after cardiac surgery placebo will be given once

Also known as: Placebo

Placebo

Lithium Carbonate DRUG

On day 0, the day of the cardiac surgery oral lithium will be given at dose 900mg once On day 1, one day after cardiac surgery oral lithium will be given at dose 900mg once On day 2, two days after cardiac surgery oral lithium will be given 900mg once

Also known as: Lithium

Lithium

Eligibility Criteria

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

You may qualify if:

• A male or female greater than 18 years
• Stable renal function with creatinine change \<0.3mg/dl in the preceding 1 month prior to scheduled surgery
• Procedure such as aortic valve surgery, mitral valve surgery, coronary artery bypass grafting, or combination of the above mentioned procedures
• Have estimated glomerular filtration rate greater than or equal to 15ml/min/ 1.73m2 as calculated by chronic kidney disease Epidemiology Collaboration (CKD-EPI) formula

You may not qualify if:

• Subjects who:
• Are taking lithium prior to surgery for any reason
• Have ejection fraction of \<30% prior to surgery
• Have estimated glomerular filtration rate \<15ml/min/ 1.73m2 as calculated by chronic kidney disease Epidemiology Collaboration (CKD-EPI) formula
• Having cardiac surgery to be performed without using cardiopulmonary bypass
• Has ongoing sepsis or history of sepsis in the last 2 weeks, defined as having 2 of the following criteria T \>38C or \<36C, pulse rate \>90/min, RR \>20/min, WBC \>12 or \>10% polymorphonuclear cells plus a documented source
• Has documented rise in creatinine ≥ 0.3mg/dl in the preceding one month prior to surgery

Sponsors & Collaborators

• Lifespan: lead

Related Publications (7)

• Reddy DS, Reddy MS. Serum Lithium Levels: Ideal Time for Sample Collection! Are We Doing it Right? Indian J Psychol Med. 2014 Jul;36(3):346-7. doi: 10.4103/0253-7176.135399.

  PMID: 25035570 RESULT

• Vives M, Wijeysundera D, Marczin N, Monedero P, Rao V. Cardiac surgery-associated acute kidney injury. Interact Cardiovasc Thorac Surg. 2014 May;18(5):637-45. doi: 10.1093/icvts/ivu014. Epub 2014 Feb 16.

  PMID: 24535092 RESULT

• Gammelager H, Christiansen CF, Johansen MB, Tonnesen E, Jespersen B, Sorensen HT. Five-year risk of end-stage renal disease among intensive care patients surviving dialysis-requiring acute kidney injury: a nationwide cohort study. Crit Care. 2013 Jul 22;17(4):R145. doi: 10.1186/cc12824.

  PMID: 23876346 RESULT

• Coleman MD, Shaefi S, Sladen RN. Preventing acute kidney injury after cardiac surgery. Curr Opin Anaesthesiol. 2011 Feb;24(1):70-6. doi: 10.1097/ACO.0b013e3283422ebc.

  PMID: 21157303 RESULT

• Gong R, Wang P, Dworkin L. What we need to know about the effect of lithium on the kidney. Am J Physiol Renal Physiol. 2016 Dec 1;311(6):F1168-F1171. doi: 10.1152/ajprenal.00145.2016. Epub 2016 Apr 27.

  PMID: 27122541 RESULT

• Bao H, Ge Y, Wang Z, Zhuang S, Dworkin L, Peng A, Gong R. Delayed administration of a single dose of lithium promotes recovery from AKI. J Am Soc Nephrol. 2014 Mar;25(3):488-500. doi: 10.1681/ASN.2013040350. Epub 2014 Jan 9.

  PMID: 24408869 RESULT

• Sharif S, Chen B, Brewster P, Chen T, Dworkin L, Gong R. Rationale and Design of Assessing the Effectiveness of Short-Term Low-Dose Lithium Therapy in Averting Cardiac Surgery-Associated Acute Kidney Injury: A Randomized, Double Blinded, Placebo Controlled Pilot Trial. Front Med (Lausanne). 2021 Jun 14;8:639402. doi: 10.3389/fmed.2021.639402. eCollection 2021.

  PMID: 34195206 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Lithium Carbonate; Lithium

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Metals, Alkali; Elements; Metals, Light; Metals

Central Study Contacts

sairah sharif

CONTACT

sairah.sharif1@gmail.com; sairah.sharif@lifespan.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients and investigators will be blinded to the study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients will be randomized to lithium versus placebo and rates of acute kidney injury will be measured

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 17, 2017
• Study Start: April 1, 2017
• Primary Completion: December 30, 2017
• Study Completion: January 1, 2018
• Last Updated: February 17, 2017

Record last verified: 2017-02