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Study of Stroke Related Edema Treatments

NCT01954290 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-12-14

No results posted yet for this study

Summary

Stroke remains the fourth leading cause of death in the United States (second worldwide) and a leading cause of long-term disability, resulting in total direct and indirect costs of approximately $73.7 billion annually. The failure of novel therapies in clinical trials demonstrates that the complex neural response to stroke must be targeted at multiple levels to improve patient outcomes. Despite significant improvements in stroke treatment and management, 1 year survival rate among stroke patients aged 65 years or more is around 25%, and 5- year survival rate amounts to approximately 50%. The highest chances of death are within 30 days of stroke. Mortality increases due to worsening brain dysfunction, elevated intracranial pressure (ICP), and other comorbid conditions.

Treatments aimed at reducing post-stroke cytotoxic edema may reduce the risk for development of malignant stroke and mortality. Current treatments such as osmo-therapy and hemicraniectomy have substantial limitations, and mortality remains high, despite these measures outcomes remain unsatisfactory. There is a great need for alternative medical approaches which are safe, predictable, and help to ameliorate post stroke edema.

Conditions

  • Acute Cerebrovascular Accident
  • Cerebral Edema

Interventions

DRUG

Conivaptan

Intravenous conivaptan 20 mg infused over 30 minutes as a loading dose, followed by a continuous infusion of 20 mg over 24 hours (0.83 mg/hour) for 2-4 days; may increase to a maximum dose of 40 mg over 24 hours (1.7 mg/hour) if serum sodium is not rising sufficiently; total duration of therapy not to exceed 4 days.

DRUG

Hypertonic saline

Hypertonic saline in the dose of 30ml/hr, with every 4 hourly measurements of serum osmolarity, serum sodium and potassium. Hypertonic saline will be increased by 30 ml to achieve target serum sodium of 150-160 and serum osmolarity 300-320

DRUG

Mannitol

Mannitol given at the dose of 0.5 to 1.0 gm/kg IV over 10-20 minutes. Maximum effect is seen in 20 minutes and duration of action is 4 hours. Repeat doses of 0.25 to 0.5 gm/kg Q 4-6 hours are normally frequently used.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Vishnumurthy Shushuthra Hedna, MD · University of Florida

  • Michael F Waters, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-09-30
Completion
2015-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01954290 on ClinicalTrials.gov