Levosimendan in Acute Kidney Injury Study | NCT01720030

Studies
Levosimendan in Acute Kidney Injury Study

NCT01720030

Sponsor

VieCuri Medical Centre

Status

Unknown status

Last Update Posted

Sep 27, 2016Estimated

Enrollment

68Actual

Phase

Phase 2Phase 3

Conditions

Acute Kidney Injury

Interventions

Levosimendan
Conventional therapy

Countries

Netherlands

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Oct 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Oct 3, 2012

First Submission Date that Met QC Criteria

Oct 30, 2012

First Posted Date

Nov 1, 2012Estimated

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

Sep 26, 2016

Last Update Posted Date

Sep 27, 2016Estimated

Name	Class
Orion Corporation, Orion Pharma	INDUSTRY

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

We hypothesise that levosimendan will have a positive influence on renal function during acute kidney injury in adult intensive care patients.

Detailed Description

The purpose of this trial is to evaluate whether the use of levosimendan is able to improve renal function.

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional therapy	Placebo Comparator	Standard of care as protocolized locally	Drug: Conventional therapy
Levosimendan	Experimental	The experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI.	Drug: Levosimendan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levosimendan	Drug	Verum therapy	Levosimendan	Simdax (R)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in renal function	Daily analysis of kidney function expressed in endogenous creatinine clearance	Baseline and every 24 hours until end ICU stay

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinically diagnosed adult patients with AKI

Exclusion Criteria:

Failure to obtain written consent to participate from patient or legal representative (by deferred consent)
Patients entering the ICU for post-operative observation with an estimated length of stay less than 24 hrs.
Moribund patients
Patients under the age of 18
Pregnancy
Patients suffering from pre-existing renal failure (elevated NGAL values without apparent rise in creatinine values)
Renal replacement therapy initiated before admission due to Chronic Kidney Disease
Hypersensitivity to levosimendan experienced by previous treatments
Severe hypotension and tachycardia
Significant mechanical obstruction affecting ventricular filling or outflow or both.
Severe hepatic impairment (ALAT/ASAT>400U/L)
Patients will be excluded if the treating physician judges that study participation is undesirable for medical, medical-ethical or other reasons
Known history of Torsades de Pointes

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

Name	Affiliation	Role
Jos Le Noble, MD PhD	VieCuri Medical Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VieCuri Medical Center		Venlo	Limburg	NL-5912 BL	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077464	Simendan
D059039	Standard of Care

Ancestor Terms

ID	Term
D006835	Hydrazones
D006834	Hydrazines
D009930	Organic Chemicals
D011724	Pyridazines

Browse Leaves

Not provided

Browse Branches

Not provided