HyponatremiaPhase 3NCT00684164
Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients
A Phase 3 study testing Conivaptan and D5 in people with Hyponatremia, run by Columbia University at 1 site in United States.
Trial summary
Low sodium levels (hyponatremia) are a frequent occurrence in medically ill patients, and in particular those with neurological injury. Hyponatremia has been associated with worse outcome, problems with memory and concentration and impaired balance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia
- What is being tested?
- Conivaptan and D5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jun 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute neurological injury
- Euvolemia or hypervolemia (defined clinically by examination, recent I+Os, BUN/creatinine ratio and CVP [if available])
- Serum sodium less than or equal to 132 mEq/L (confirmed as hypoosmolar hyponatremia by a concurrent source: osmolality measurements [<280 mosoms/L] or by a preceding serum Na+ value <135 mEq/L0
Who cannot join
- Patients who have uncontrolled hypertension; significant orthostatic hypotension or supine systolic blood pressure less than 85 mm Hg;
- Uncontrolled arrhythmias;
- Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency;
- Estimated creatinine clearance less than 20 ml/min;
- Urinary outflow obstruction unless catheterized;
- Alanine aminotransferase (ALT) >3x ULN
Show all 14Show fewer
- Aspartate aminotransferase (AST) >3x ULN
- Serum albumin of 1.5 g/dl or less;
- Prothrombin time greater than 22 sec or an international normalized ratio (INR) greater than 2.0 without anticoagulant therapy or 3.0 or more with therapy; a white blood cell count less than 3000/µl;
- HIV infection;
- Active hepatitis.
- Pregnant or nursing
- Participation in a clinical trial of an investigational drug or device within 30 days of screening
- Unable to obtain written consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Safety and Efficacy of Conivaptan for the Correction of Euvolemic and Hypervolemic Hyponatremia in Critically Ill Neurological Patients
Low sodium levels (hyponatremia) are a frequent occurrence in medically ill patients, and in particular those with neurological injury. Hyponatremia has been associated with worse outcome, problems with memory and concentration and impaired balance. Standard treatment for low sodium (salt) levels is to give the patient a salt containing solution thru a catheter (small flexible tube) in a vein in the arm or leg. One of the major complications of this treatment is excess body fluid which may cause heart problems or accumulation of fluid in the lungs and may require additional medications to remove extra water from the body.
FDA approval has recently been granted for a new drug - Conivaptan - for use in hyponatremic conditions. Conivaptan works by excreting free water from the body and thereby produce concurrent rise in serum sodium concentrations. Conivaptan has not been evaluated specifically in patients with brain injuries. The primary objective of this study is to demonstrate the safety and efficacy of intravenous Conivaptan for the treatment of hyponatremia in patients with brain injury. If effective, Conivaptan may represent a safe treatment option.
- Conditions
- Hyponatremia
- Being tested
- Conivaptan, D5
- Keywords
- Euvolemic Hyponatremia, Hypervolemic Hyponatremia, Neurological injury
- Medical subject headings
- Hyponatremia, Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConivaptanDrug
Also called VAPRISOL
20mg bolus over 30 min, and then as a 20mg infusion over 24 hours for up to 4 days
D5Other
Volume loading dose of D5 followed by an infusion of D5 over 24 hours for up to 4 days - or until the study endpoint of sodium ≥135mEq/L is reached.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects in the treatment group will receive standard medical treatment plus Conivaptan administered as a 20mg bolus over 30 min, and then as a 20mg infusion over 24 hours for up to 4 days - or until the study endpoint of sodium ≥135mEq/L is reached. Receives: Drug: Conivaptan |
| 2 | Placebo comparator | Subjects in the placebo control group will receive an equivalent volume loading dose of D5 followed by an infusion of D5 in the same manner as the experimental group. Receives: Other: D5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in serum sodium over the duration of treatment between the two treatment arms.
Measured: From beginning of treatment to return of sodium level to greater than or equal to 135 mEq/L, up to 4 days of treatment
Secondary outcomes (1)
Percentage of patients requiring study drug discontinuation for any reason other than reaching the sodium endpoint, including those with too rapid a rise in serum sodium (>12 mEq rise over 24 hours) or an infusion site reaction
Measured: From the initiation of treatment to the end of treatment, up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startMay 2008
- Primary completionNov 2009 (estimated)
- Study completionJun 2010 (estimated)
Why it stopped: Unable to complete a contract with the Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Investigators
- Stephan A. Mayer, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684164
- Sponsor's protocol ID
- AAAC6833
- Status last verified
- Mar 2015
- First submitted
- 22 May 2008
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Conivaptan for the Correction of Euvolemic and Hypervolemic Hyponatremia in Critically Ill Neurological Patients
- ClinicalTrials.gov ID
- NCT00684164
- Acronym / sponsor ID
- AAAC6833
- Conditions
- Hyponatremia
- Keywords
- Euvolemic Hyponatremia, Hypervolemic Hyponatremia, Neurological injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to complete a contract with the Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- May 2008
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 26 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low sodium levels (hyponatremia) are a frequent occurrence in medically ill patients, and in particular those with neurological injury. Hyponatremia has been associated with worse outcome, problems with memory and concentration and impaired balance. Standard treatment for low sodium (salt) levels is to give the patient a salt containing solution thru a catheter (small flexible tube) in a vein in the arm or leg. One of the major complications of this treatment is excess body fluid which may cause heart problems or accumulation of fluid in the lungs and may require additional medications to remove extra water from the body.
FDA approval has recently been granted for a new drug - Conivaptan - for use in hyponatremic conditions. Conivaptan works by excreting free water from the body and thereby produce concurrent rise in serum sodium concentrations. Conivaptan has not been evaluated specifically in patients with brain injuries. The primary objective of this study is to demonstrate the safety and efficacy of intravenous Conivaptan for the treatment of hyponatremia in patients with brain injury. If effective, Conivaptan may represent a safe treatment option.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ConivaptanSubjects in the treatment group will receive standard medical treatment plus Conivaptan administered as a 20mg bolus over 30 min, and then as a 20mg infusion over 24 hours for up to 4 days - or until the study endpoint of sodium ≥135mEq/L is reached. |
| 2 | Placebo comparator | Other: D5Subjects in the placebo control group will receive an equivalent volume loading dose of D5 followed by an infusion of D5 in the same manner as the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute neurological injury
- Euvolemia or hypervolemia (defined clinically by examination, recent I+Os, BUN/creatinine ratio and CVP [if available])
- Serum sodium less than or equal to 132 mEq/L (confirmed as hypoosmolar hyponatremia by a concurrent source: osmolality measurements [<280 mosoms/L] or by a preceding serum Na+ value <135 mEq/L0
Key exclusion criteria (14 listed)
- Patients who have uncontrolled hypertension; significant orthostatic hypotension or supine systolic blood pressure less than 85 mm Hg;
- Uncontrolled arrhythmias;
- Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency;
- Estimated creatinine clearance less than 20 ml/min;
- Urinary outflow obstruction unless catheterized;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConivaptanAlso: VAPRISOL20mg bolus over 30 min, and then as a 20mg infusion over 24 hours for up to 4 days | Drug | 1 |
| D5Volume loading dose of D5 followed by an infusion of D5 over 24 hours for up to 4 days - or until the study endpoint of sodium ≥135mEq/L is reached. | Other | 2 |
Primary outcome
Mean change in serum sodium over the duration of treatment between the two treatment arms.
Time frame: From beginning of treatment to return of sodium level to greater than or equal to 135 mEq/L, up to 4 days of treatment
1 secondary outcome
Percentage of patients requiring study drug discontinuation for any reason other than reaching the sodium endpoint, including those with too rapid a rise in serum sodium (>12 mEq rise over 24 hours) or an infusion site reaction
Time frame: From the initiation of treatment to the end of treatment, up to 4 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
Related trials for Hyponatremia
RecruitingPhase 3
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Hyponatremia
Enrolling by invitationObservational study
International Multi-center Retrospective Study of Patients With Serum Sodium ≤110 mmol/L to Determine the Relationship Between Osmotic Demyelination Syndrome (ODS) and Rapid Correction of Hyponatremia
Hyponatremia Symptomatic, Osmotic Demyelination Syndrome
Active, not recruitingObservational study
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
Antidiuretic Hormone, Inappropriate Secretion
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Active, not recruitingObservational study
Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care
Hyponatremia, Osmotic Demyelination Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan A. Mayer, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conivaptan and D5 in people with Hyponatremia, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in serum sodium over the duration of treatment between the two treatment arms. (time frame: From beginning of treatment to return of sodium level to greater than or equal to 135 mEq/L, up to 4 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.