N-acetylcysteine Plus Deferoxamine for Patients With Hypo... | NCT00870883

Studies
N-acetylcysteine Plus Deferoxamine for Patients With Hypotension

NCT00870883

Sponsor

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Status

Completed

Last Update Posted

May 28, 2015Estimated

Enrollment

81Actual

Phase

Phase 2

Conditions

Hypotension
Acute Renal Failure

Interventions

N-acetylcysteine and deferoxamine

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Mar 25, 2009

First Submission Date that Met QC Criteria

Mar 25, 2009

First Posted Date

Mar 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2015

Last Update Posted Date

May 28, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Felipe Dal Pizzol, MD, PhD, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudePrincipal Investigator

Lead Sponsor

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudeOTHER

Collaborators

Name	Class
Conselho Nacional de Desenvolvimento Científico e Tecnológico	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Oxidative stress is associated with kidney damage in several different situations, including hypotension. In animal models it has been shown that the combination of n-acetylcysteine plus deferoxamine is superior to its isolate use in the treatment of several diseases. Thus the investigators aimed to determine if the administration of n-acetylcysteine plus deferoxamine could prevent renal failure in critical ill patients who develops hypotension.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
N-acetylcysteine plus deferoxamine	Experimental		Drug: N-acetylcysteine and deferoxamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N-acetylcysteine and deferoxamine	Drug	N-acetylcysteine bolus dose of 50mg/kg/4h, by a manutention of 100mg/kg/day during 2 days and deferoxamine single dose of 1g administered 15mg/kg/h.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Development of acute renal failure		28 days

Secondary Outcomes

Measure	Description	Time Frame
28 day-mortality		28 days
Decrease on plasma oxidative damage and inflammatory parameters		at the end of drug infusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to the ICU
Presenting hypothesion (MAP < 60mm Hg or the needing to use vasoactive drugs) for at least 30 min in the last 12h before study inclusion

Exclusion Criteria:

Age lower than 18 years old
Chronic renal failure
A known history of allergy to any of the study drugs
Using n-acetylcysteine to paracetamol overdose
Pregnant women
Patients who used iodinated contrast medium
Hemoglobin less than 6.5 mg/dl
Cancer patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
São José Hospital		Criciúma	Santa Catarina	88801250	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27745551	Derived	Fraga CM, Tomasi CD, Damasio DC, Vuolo F, Ritter C, Dal-Pizzol F. N-acetylcysteine plus deferoxamine for patients with prolonged hypotension does not decrease acute kidney injury incidence: a double blind, randomized, placebo-controlled trial. Crit Care. 2016 Oct 17;20(1):331. doi: 10.1186/s13054-016-1504-1.
22045831	Derived

ID	Term
D007022	Hypotension
D058186	Acute Kidney Injury

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D051437	Renal Insufficiency
D007674	Kidney Diseases

ID	Term
D000111	Acetylcysteine
D003676	Deferoxamine

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals