Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure

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Primary Purpose

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Hypertonic Saline, Mannitol

About this trial

This is an interventional treatment trial for Increased Intracranial Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Reduction of ICP below treatment threshold (less than 20 mmHg)

Secondary Outcome Measures

Compare effects of each treatment on MAP, CPP, serum and urine sodium and osmolality

Full Information

NCT ID

NCT00359697

First Posted

August 1, 2006

Last Updated

November 5, 2014

Sponsor

Thomas Jefferson University

1. Study Identification

Unique Protocol Identification Number

NCT00359697

Brief Title

Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure

Official Title

Prospective, Randomized Clinical Trialto Compare Mannitol and Hypertonic Saline for Treatment of Increased Intracranial Pressure

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thomas Jefferson University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Increased Intracranial Pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Hypertonic Saline, Mannitol

Primary Outcome Measure Information:

Title

Reduction of ICP below treatment threshold (less than 20 mmHg)

Secondary Outcome Measure Information:

Title

Compare effects of each treatment on MAP, CPP, serum and urine sodium and osmolality

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert H Rosenwasser, MD

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Increased Intracranial Pressure

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial