Spironolactone Administration to Prevent Ischemic Kidney Injury in Critically Ill Cancer Patients

NCT02531412 | Unknown Phase 2 DMC

• 1 other identifier: CEI/993
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Acute kidney injury frequently affects cancer patients. The main cause of acute kidney injury is ischemic damage caused by transient decrease in renal blood flow, followed by blood flow restoration and accompanying reperfusion injury (ischemia-reperfusion injury. Several studies, mainly in animal models have tried to establish spironolactone role on kidney injury induced by ischemia-reperfusion injury. It has been demonstrated in renal transplant recipients that the administration of spironolactone can prevent oxidative stress and is safe. The group of cancer patients with states capable of producing tissue hypoperfusion (hypovolemic shock, heart failure, major surgery, use of anesthetics) are at increased risk of developing acute renal ischemia-reperfusion injury. The investigators hypothesis is that spironolactone may be useful in preventing acute renal injury when administered during the first six hour of renal ischemia-reperfusion insult. The purpose of this study is to determine the utility of spironolactone administered after an ischemic renal insult (major surgery) to prevent acute kidney injury in critically cancer patients. Investigators propose a pilot study, randomized, double blind, placebo controlled trial, approved by the local ethical committee, to compare the efficacy of spironolactone to prevent acute kidney injury in patients after major surgery. Investigators will include 12 patients in spironolactone group (25mg daily for three days) and 12 patients in placebo group.

Conditions

Critically Ill; Cancer

Keywords

Acute kidney injury; Critically ill cancer patients; Spironolactone

Outcome Measures

Primary Outcomes (3)

• Acute kidney injury by 0.3 creatinine elevation

  Elevation of creatinine to 0.3mg/dL above baseline in the last 48 hours

  48 hours

• Acute kidney injury by 1.5 times creatinine elevation

  Elevation of baseline creatinine 1.5 times above baseline

  48 hours

• Acute kidney injury by urinary output

  Decreased urine output less than 0.5ml/kg/hr over a period of 6 continuous hours somewhere during the first 48 hours monitoring, after admission to the intensive care unit

  48 hours

Secondary Outcomes (1)

• Hyperkalemia

  Up to 5 days

Study Arms (2)

Spironolactone

EXPERIMENTAL

Spironolactone 25 mg PO daily for three days. During five days investigators will collect values of plasma creatinine, sodium, potassium, blood ureic nitrogen, vital signs and urinary output.

Drug: Spironolactone

Placebo

PLACEBO COMPARATOR

Placebo 25mg PO daily for three days During five days investigators will collect values of plasma creatinine, sodium, potassium, blood ureic nitrogen, vital signs and urinary output.

Drug: Placebo

Interventions

Spironolactone DRUG

After a major surgery event a time 0, 24h and 48h

Also known as: Aldactone

Spironolactone

Placebo DRUG

After a major surgery event a time 0, 24h and 48h

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the ICU in the immediate postoperative period (first 24 hours) of major surgery, defined as involving general anesthesia, ventilation, opening of large cavities (cranial, thoracic, abdominal).
• Patients with informed consent signed by them or their responsible relative.
• Patients who are likely to survive at least 48 hours after admission to the ICU.
• Patients who have measured "baseline" creatinine before UCI admission, in the last three months.

You may not qualify if:

• Patients who have contraindications for enteral medications.
• Patients who have acute kidney injury at the time of admission.
• Patients on renal replacement therapy prior to ICU admission.
• Patients with previous diagnosis of chronic kidney disease G3b stage.
• Patients with plasma potassium greater than 5.1mEq/L.
• Hypersensitivity to spironolactone.
• Septic shock.
• Obstructive uropathy.
• Renal transplantation.
• Postoperative period of nephrectomy.
• Pregnancy.
• Known adrenal insufficiency.
• Patients requiring a higher dose of norepinephrine 0.1mcg/kg/min for more than an hour to maintain mean arterial pressure equal to or greater than 70mmHg even after receiving fluid resuscitation.
• Patients requiring the administration of inhibitors of angiotensin-converting enzyme (ACE) for its management.
• Patients requiring an increase of 25% or more of the dose of norepinephrine to maintain mean arterial pressure equal of greater than 70mmHg during follow up.

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

Nacional Cancer Institute

Mexico City, Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Critical Illness; Neoplasms; Acute Kidney Injury

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bertha M Cordova-Sanchez, MD

  Instituto Nacional de Cancerologia, Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertha M Cordova-Sanchez, MD

CONTACT

5556280400; berthax@hotmail.com

Silvio A Ñamendys-Silva, MD

CONTACT

5556280400; snamendys@incan.edu.mx

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: MD

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 24, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 4, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)