Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Res... | NCT00529490

Studies
Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats

NCT00529490

Sponsor

Innogene Kalbiotech Pte. Ltd

Status

Completed

Last Update Posted

Sep 14, 2007Estimated

Enrollment

230Actual

Phase

Phase 3

Conditions

Low Cardiac Output

Interventions

Hypertonic lactate
Ringer's lactate

Countries

Indonesia

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 2007

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 2002

Primary Completion Date

Not provided

Completion Date

Jun 2003Actual

First Submitted Date

Sep 12, 2007

First Submission Date that Met QC Criteria

Sep 12, 2007

First Posted Date

Sep 14, 2007Estimated

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 12, 2007

Last Update Posted Date

Sep 14, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible received either hypertonic lactate solution or Ringer's Lactate post-CABG in the ICU when fluid resuscitation was needed.

Detailed Description

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

230Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HL	Experimental	Hypertonic lactate group	Drug: Hypertonic lactate
RL	Active Comparator	Ringer's lactate	Drug: Ringer's lactate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypertonic lactate	Drug	Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG	HL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hemodynamic stability		12 hours post-CABG surgery

Secondary Outcomes

Measure	Description	Time Frame
Safety of hypertonic sodium lactate for maintaining the hemodynamic stability		12 hours post-CABG surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have given their written informed consent.
Male or female, aged 18-75 years.
Post-operative CABG on pump or off pump in ICU.
Patients who need fluid resuscitation.

Exclusion Criteria:

Combined operations.
Need for intra aortic balloon pump (IABP).
Patients with severe arrhythmia (VT, AF rapid response, heart block).
Severe hemodynamic imbalance.
Severe bleeding and/or re-operation.
Liver dysfunction(SGOT and SGPT 2x normal).
Renal failure (Creatinine >2 mg%).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Iqbal Mustafa, MD	National cardiac Centre, Harapan Kita Hospital, Dept. of Anaesthesiology, Intensive Care Unit, Jakarta, Indonesia	Principal Investigator
Xavier Leverve, MD, PhD	Director, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université, Joseph Fourier, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cardiac Center, Department of Surgery and Intensive Care Unit, Harapan Kita Hospital		Jakarta	Jakarta Special Capital Region		Indonesia

Condition Browse Module

MeSH Terms

ID	Term
D002303	Cardiac Output, Low

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077325	Ringer's Lactate

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided