Comparison of Two Different Medications Used to Treat Ele... | NCT00359697

Studies
Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure

NCT00359697

Sponsor

Thomas Jefferson University

Status

Unknown status

Last Update Posted

Nov 6, 2014Estimated

Enrollment

50Estimated

Phase

Phase 1

Conditions

Increased Intracranial Pressure

Interventions

Hypertonic Saline, Mannitol

Countries

Not provided

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

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 1, 2006

First Submission Date that Met QC Criteria

Aug 1, 2006

First Posted Date

Aug 2, 2006Estimated

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

Nov 5, 2014

Last Update Posted Date

Nov 6, 2014Estimated

Description Module

Brief Summary

The overall purpose of this study is to compare the effects of mannitol and hypertonic saline on patients with increased intracranial pressure. The hypothesis being tested is that hypertonic saline is more effective in controlling increased intracranial pressure than mannitol.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Hypertonic Saline, Mannitol	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of ICP below treatment threshold (less than 20 mmHg)

Secondary Outcomes

Measure	Description	Time Frame
Compare effects of each treatment on MAP, CPP, serum and urine sodium and osmolality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Documented SAH (by computed tomography or lumbar puncture), ICH, TBI or brain tumor
Patient greater than or equal to 18 years of age
ICP monitor in place
ICP greater than 20mmHg, not related to a transient noxious stimulus and not responding to standard measures for controlling ICP (ventricular drainage, elevation of head of the bed and optimizing PaCO2)
Patient or patient's legally authorized representative has provided written informed consent

Exclusion Criteria:

Patient less than 18 years of age
Lack of ICP monitoring
Patient received Mannitol prior to placement of ICP monitor
Baseline serum osmolarity of greater than 310 mOsm/L
Patient is currently enrolled in another investigational drug or device study
Congestive heart failure at time of enrollment
Chronic renal failure on hemodialysis
Pregnancy

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

Name	Affiliation	Role
Robert H Rosenwasser, MD	Thomas Jefferson University	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D019586	Intracranial Hypertension

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012462	Saline Solution, Hypertonic
D008353	Mannitol

Ancestor Terms

ID	Term
D006982	Hypertonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D013402	Sugar Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided