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Trial record 2 of 4 for:    12081583 [PUBMED-IDS]

Spironolactone on Acute Kidney Injury in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT03206658
Recruitment Status : Not yet recruiting
First Posted : July 2, 2017
Last Update Posted : July 6, 2017
Sponsor:
Collaborators:
National Council of Science and Technology, Mexico
Universidad Nacional Autonoma de Mexico
Information provided by (Responsible Party):
Norma Bobadilla, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary:

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: spironolactone
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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients older than 18 years of age
  • Patients critically ill requiring invasive mechanical ventilation with some organic failure in addition to respiratory failure.

Organic scale failure will be categorized according to the (Sequential Organ Failure Assesment) scale and will be considered present when there is a score ≥2 in some organ / system, except renal.

  • Patients with normal renal function or chronic kidney disease KDOQI 1-3
  • Patients without acute renal injury according to the (acute kidney injury network) AKIN criteria.
  • Normal serum K levels (less than or equal to 5 mEq / L).
  • Women with (a) negative pregnancy test, (b) surgical sterilization, or (c) completed menopause.
  • Systolic blood pressure> 90 mmHg and mean arterial pressure> 70 mmHg.
  • Diuresis in the first 6 hrs from admission to intensive therapy> 0.5 ml / kg / hr.
  • The patient will give written and signed informed consent prior to any specific study procedure. However, if a patient can not do so before, his or her legal representative the Institute may give written informed consent.

Exclusion Criteria:

  • Patients with chronic kidney disease stages 4-5 of KDOQI / renal replacement therapy.
  • Patients with acute kidney injury according to the AKIN criteria at the time of admission to the intensive care unit
  • Patients with refractory septic shock, defined as a state of hypotension requiring administration of ≥0.25 mcg / kg / min of noradrenaline.
  • Patients with known adrenal insufficiency.
  • Patients with indication for the administration of angiotensin-converting enzyme (ACE) blockers or angiotensin 2 receptor antagonists.
  • Known allergy to spironolactone.
  • Contraindication for orally medication or placement of any probe (SNG or SNE)
  • It is considered that the patient is unlikely to survive the study period (30 days) or has a disease of rapid or terminal progression.
  • The patient is participating in any other clinical trial involving the administration of a research drug at the time of the presentation during the course of the study or has been treated with a research drug within 30 days prior to enrollment.
  • The patient has been enrolled in this study previously.
  • The patient is pregnant or breastfeeding.

Information from the National Library of Medicine

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


Contacts
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Contact: Norma Bobadilla-Sandoval, PhD +5215532327451 nab@biomedicas.unam.mx
Contact: Mauricio Arvizu, MD +5215527030681 arvizumh@gmail.com

Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
National Council of Science and Technology, Mexico
Universidad Nacional Autonoma de Mexico
Investigators
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Principal Investigator: Norma Bobadilla-Sandoval, PhD INCMNSZ / IBB UNAM

Publications of Results:

Other Publications:

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Responsible Party: Norma Bobadilla, PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT03206658     History of Changes
Other Study ID Numbers: 1251
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norma Bobadilla, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
acute kidney injury
prevention
severity
biomarker

Additional relevant MeSH terms:
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Wounds and Injuries
Critical Illness
Acute Kidney Injury
Disease Attributes
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents