A Phase 4 interventional study of Placebo oral capsule and Lithium Carbonate in Acute Kidney Injury, sponsored by Lifespan. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-17.
Sponsored by Lifespan · Phase 4, Interventional, and Prevention
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.
Cardiac surgery associated acute kidney injury (CSA-AKI) is a significant problem. The prevalence varies from 0.3% to 22.9% depending on the definition of AKI. The pathogenesis of AKI in this population is multifactorial. Factors associated with AKI in such patients include increased age, preoperative elevated creatinine, presence of diabetes, reduced ejection fraction, increased body weight, and presence of carotid artery bruit, duration of cardiopulmonary bypass, aortic cross clamp time, and duration of surgery. CSA-AKI is an independent predictor of mortality, morbidity, increased length of stay and hospitalization costs. Moreover these patients are also at increased risk of chronic kidney disease and end stage renal failure in the future.
Various pharmacologic approaches that have been tried to prevent early CSA-AKI such as diuretics, vasodilators, and anti-inflammatory drugs. Fenoldopam, atrial natriuretic peptide, and brain natriuretic peptide have shown little renoprotection. However these strategies lack high quality evidence to support their use and are not standard of care. There is no strong evidence to suggest any single or multiple pharmacotherapy that significantly impacts in reducing CAS-AKI. Thus the current best therapy for CSA-AKI is prevention, supportive care, hemodynamic optimization and renal replacement therapy.
AKI is an extremely complex process involving multiple pathophysiologic pathways. Glycogen synthase kinase 3β (GSK3β) is implicated in many pathways beyond glycogen metabolism and has been shown to be an important player in the development of AKI . Lithium is a US Food and Drug Administration (FDA)-approved drug which has been used for over 50 years as first line agent to treat mood disorders. It is a standard inhibitor for GSK3β. Latest evidence in murine models of cisplatin-induced AKI and ischemia/reperfusion-induced AKI suggests that lithium treatment may attenuated kidney dysfunction and kidney histologic injury following AKI. Lithium was able to promote kidney tubular cell repair hence improvement of AKI in murine models. In addition, lithium has also been found to exert an anti-proteinuric and renal reparative effect. On this background we want to explore the potential preventive and therapeutic role of lithium carbonate in CSA- AKI.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
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Exclusion Criteria:
Subjects who:
Patients will be identified by chart review and be explained the purpose of the study and informed consent taken
Drug: Lithium Carbonate
Patients will be identified by chart review and be explained the purpose of the study and informed consent taken
Drug: Placebo oral capsule
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
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
Change in serum creatinine mg/dl
Renal function
Time frame: 1 month
Peak creatinine mg/dl
Renal function
Time frame: 1 month
Neutrophil gelatinase-associated lipocalcin (NGAL) ng/ml
Renal function
Time frame: 3 days
Kidney injury molecule-1 (KIM1) ng/ml
Renal function
Time frame: 3 days
No study locations are listed for this record.
Plan to share: Undecided
This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Lifespan