Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients

This study has been terminated.

( Enrollment below goal. )

Study NCT00727090 Information provided by Northwestern University

First Received on July 30, 2008. Last Updated on September 27, 2010 History of Changes

Results First Received: July 21, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Treatment
Condition:	Hyponatremia
Intervention:	Drug: Conivaptan

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Treatment: Conivaptan	Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
Usual Medical Care	Usual care by the attending physician staff

Participant Flow: Overall Study

	Treatment: Conivaptan	Usual Medical Care
STARTED	3	3
COMPLETED	3	3
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Treatment: Conivaptan	Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
Usual Medical Care	Usual care by the attending physician staff

Baseline Measures

	Treatment: Conivaptan	Usual Medical Care	Total
Number of Participants [units: participants]	3	3	6
Age [units: years] Mean ± Standard Deviation	43 ± 22.0	67 ± 2	55 ± 19.2
Age, Customized [units: participants]
<=18 years	0	0	0
Between 18 and 70 years	3	3	6
>70 years	0	0	0
Gender [units: participants]
Female	0	1	1
Male	3	2	5
Region of Enrollment [units: participants]
United States	3	3	6

Outcome Measures

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1. Primary:

Change in Serum Sodium From Baseline to 6 Hours [ Time Frame: 48 hours ]

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2. Other Pre-specified:

Change in Serum Sodium From Baseline to 12 Hours [ Time Frame: 12 hours ]

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3. Other Pre-specified:

Change in Serum Sodium From Baseline to 18 Hours [ Time Frame: 18 hours ]

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4. Other Pre-specified:

Change in Serum Sodium From Baseline to 24 Hours [ Time Frame: 24 hours ]

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5. Other Pre-specified:

Change in Serum Sodium From Baseline to 36 Hours [ Time Frame: 36 hours ]

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6. Other Pre-specified:

Change in Serum Sodium From Baseline to 48 Hours [ Time Frame: 48 hours ]

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7. Secondary:

NIH Stroke Scale [ Time Frame: 48 hours ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

8. Secondary:

Glasgow Coma Scale [ Time Frame: 48 hours ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Andrew M Naidech
Organization: Northwestern University
phone: 312-503-3592
e-mail: a-naidech@northwestern.edu

No publications provided by Northwestern University

Publications automatically indexed to this study:

Naidech AM, Paparello J, Leibling SM, Bassin SL, Levasseur K, Alberts MJ, Bernstein RA, Muro K. Use of Conivaptan (Vaprisol) for hyponatremic neuro-ICU patients. Neurocrit Care. 2010 Aug;13(1):57-61.

Responsible Party:	Andrew Naidech, Northwestern University
ClinicalTrials.gov Identifier:	NCT00727090 History of Changes
Other Study ID Numbers:	1507-10
Study First Received:	July 30, 2008
Results First Received:	July 21, 2010
Last Updated:	September 27, 2010
Health Authority:	United States: Institutional Review Board