The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide.

NCT04393493 | Completed Phase 2 Results DMC

• 1 other identifier: 112/17
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

In double-blind clinical trial, determine renal recovery with two different furosemide strategies in patients with type 1 cardiorenal syndrome.

Conditions

Cardiorenal Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Renal Function Recovery Defined as a Return to Individual Baseline Serum Creatinine Values

  Comparing patient's baseline serum creatinine (previous serum creatinine of 3 months ago and up to a year ago) with creatinine measurements every 24 hours during intervention (4 days)

  Up to 96 hours after intervention started

Secondary Outcomes (9)

• Change in 24 Hour Urine Output at 96 Hours After Intervention Started From 24 Hour Urine Output One Day Before Intervention Initiation)

  96 hours after intervention started

• Change in Serum Creatinine at Day One of Intervention From Serum Creatinine at 96 Hrs After Intervention Started

  96 hours after intervention started

• An Elevation of at Least 0.3 mg/dl of Serum Creatinine From Day One of Intervention Compared With Serum Creatinine at 96hrs After Intervention Started

  96 hours after intervention started

• In Hospital Mortality Defined as Number of Dead Patients From Day One of Intervention and Before Discharge

  From day one of intervention up to discharge, an average of 1 week

• Mortality During Follow up Defined as Number of Dead Patients After Discharge

  From day one after discharge up to an average of 161 days

Other Outcomes (14)

• Change in Serum Copeptin Levels at Day One of Intervention From Serum Copeptin Levels Measured at 96 Hrs After Intervention Started.

  96 hours after intervention started

• Change in Serum Brain Natriuretic Peptide Levels at Baseline From Serum Brain Natriuretic Peptide Levels at 96 Hours After Intervention Started

  96 hours after intervention started

• Number of Patients That Achieved >30% Reduction in Brain Natriuretic Compared With Baseline Levels

  Up to 96 hours after intervention started

Study Arms (2)

GROUP A

EXPERIMENTAL

Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally: * Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution * Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution * Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution * Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution

Drug: Furosemide intravenous solution

GROUP B

EXPERIMENTAL

Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally: * Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs. * Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs. * Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs. * Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.

Drug: Furosemide intravenous solution; Drug: Chlortalidone; Drug: Spironolactone

Interventions

Furosemide intravenous solution DRUG

Administrated as an 80 mg intravenous bolus every 24 hours in both arms and then as a continuous infusion dosed according to the experimental arm.

GROUP A; GROUP B

Chlortalidone DRUG

One 50 mg pill administrated every 24 hours in group B

GROUP B

Spironolactone DRUG

One 50 mg pill administrated every 24 hours in group B

GROUP B

Eligibility Criteria

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

You may qualify if:

• Comply with both clinical diagnosis of acute kidney injury by serum creatinine according to the Kidney Disease Improving Global Outcomes (KDIGO) 2012 guidelines and acute decompensate heart failure as clinical assessed by the clinical team in charge.
• Have agreed and signed informed consent

You may not qualify if:

• Patient in chronic dialysis either peritoneal dialysis or hemodialysis.
• History of being a renal transplant recipient
• History of acute kidney injury according to the KDIGO 2012 guidelines and / or renal replacement therapy in the last 3 months
• Pregnancy
• Impossibility to administer medication by the oral route

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (2)

HCG

Guadalajara, Jalisco, 44240, Mexico

Location

Hospital Civil de Guadalajara

Guadalajara, Jalisco, 44240, Mexico

Location

Related Publications (1)

• Chavez-Iniguez JS, Ibarra-Estrada M, Sanchez-Villaseca S, Romero-Gonzalez G, Font-Yanez JJ, De la Torre-Quiroga A, de Quevedo AA, Romero-Munoz A, Maggiani-Aguilera P, Chavez-Alonso G, Gomez-Fregoso J, Garcia-Garcia G. The Effect in Renal Function and Vascular Decongestion in Type 1 Cardiorenal Syndrome Treated with Two Strategies of Diuretics, a Pilot Randomized Trial. BMC Nephrol. 2022 Jan 3;23(1):3. doi: 10.1186/s12882-021-02637-y.

  PMID: 34979962 DERIVED

MeSH Terms

Conditions

Cardio-Renal Syndrome

Interventions

Chlorthalidone; Spironolactone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr Jonathan Chavez Iñiguez
• Organization: hospital civil de guadalajara

jonarchi_10@hotmail.com

3313299609

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind clinical trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Its a randomized, controlled, phase II, 2-arm, double-blind clinical trial

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: May 19, 2020
• Study Start: July 1, 2017
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: September 14, 2020
• Results First Posted: September 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)