Spironolactone on Acute Kidney Injury in Critically Ill Patients
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|ClinicalTrials.gov Identifier: NCT03206658|
Recruitment Status : Unknown
Verified July 2017 by Norma Bobadilla, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Recruitment status was: Not yet recruiting
First Posted : July 2, 2017
Last Update Posted : July 6, 2017
This study was designed to evaluate the effect of spironolactone administration in the incidence and severity of AKI in patients critically ill with invasive mechanical ventilation (IMV) in the critical care unit.
Patients in critical care unit (CCU) are the most at risk of developing AKI. In most cases a mechanism of ischemia/reperfusion has a central role in the development of AKI. Aldosterone has traditionally been recognized as a mediator that maintains water and sodium homeostasis. Nevertheless, there are enough evidence in humans and experimental models that aldosterone might mediate detrimental effects on renal function and structure in pathophysiological conditions. Indeed, several experimental studies from our laboratory have shown that mineralocorticoid receptor blockade protects the kidney against ischemia/reperfusion injury.
The aim of this study is to know:
o If mineralocorticoid receptor blockade may reduce the incidence and severity of AKI in critically patients with IMV in CCU.
You may be able to enter in this study if:
- You are at least 18 years old.
- You are male or female
- You are with IMV.
- You are in CCU.
- Your serum K is less than 4.5 mEq/L
- Your BP is >90/70 mmHg
You cannot enter this study if:
- You have CKD
- You have AKI
This study will recruit 90 patients from Instituto Nacional de Ciencias Médicas Salvador Zubiran in México City. The study will begin in April 2017. The patients will be randomized to one of 2 groups of treatment (Spironolactone 25 mg or placebo). All treatments looks identical (1 capsule), will be administered through the nasogastric tube. Neither the patients nor their doctors will be able to know or decide which group you are in. You will receive the medication during the first five days of stay in the critical care unit.
As part of this trial, the doctors will ask your permission to get a sample urine during this days. They will use the samples to do tests in the laboratory (different to routine tests) that may help them to compare renal function and biomarkers of renal injury. Your participation will end 10 days after your entry into the critical care unit. The most common side effect of spironolactone is hyperkalemia.
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury||Drug: Spironolactone 25 mg Drug: Placebo oral capsule||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Usefulness of Spironolactone for the Prevention of Acute Kidney Injury in Critically Ill Patients With Invasive Mechanical Ventilation|
|Estimated Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Placebo Comparator: placebo oral capsules
Placebo capsules equal to those in the study drug, will be administered every 24 hours for the first 5 days after entry into the critical care unit
Drug: Placebo oral capsule
The contents of a placebo capsule will be administered orally or through the nasogastric / nasoenteral tube to the patients every 24 hours, at 8-9 am.
Other Name: control group
capsules of spironolactone 25 mg equal to placebo, will be given every 24 hours for the first 5 days after entry to the critical care unit
Drug: Spironolactone 25 mg
A dose of 25 mg of spironolactone will be administered orally or through the nasogastric /nasoenteral tube to the patients every 24 hours, at 8-9 am.
Other Name: aldactone 25 mg
- level of urinary biomarkers of AKI [ Time Frame: at the day 0, 1, 2, 3 , 4, 5, 7 and 10 from the inclusion in the study ]determine the concentrations of NGAL, KIM-1, oxidative stress and Hsp72 in urine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206658
|Contact: Norma Bobadilla-Sandoval, PhDfirstname.lastname@example.org|
|Contact: Mauricio Arvizu, MDemail@example.com|
|Principal Investigator:||Norma Bobadilla-Sandoval, PhD||INCMNSZ / IBB UNAM|