NCT00004494已完成1 期
Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
研究概览
简要总结
OBJECTIVES:
I. Determine the maximum tolerated dose of vasoactive intestinal peptide in patients with acute respiratory distress syndrome.
II. Evaluate the safety and pharmacodynamic activity of this peptide in these patients.
详细描述
PROTOCOL OUTLINE:
This is a dose escalation study.
Patients receive vasoactive intestinal peptide (VIP) IV over either 6 or 12 hours.
Cohorts of 3 patients each receive escalating doses of VIP over either 6 or 12 hours until the maximum tolerated dose is determined.
Patients are followed for 30 days.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Diagnosis of adult respiratory distress syndrome (ARDS) with sepsis
- •ARDS characterized by: hypoxemia refractory to supplemental oxygen therapy, diffuse pulmonary infiltrates, no cardiogenic cause of pulmonary edema, and reduced pulmonary compliance
- •Sepsis characterized by: Two or more of the following: Fever or hypothermia; Tachycardia; Tachypnea; WBC greater than 12,000/mm3 or less than 4,000/mm3 or immature neutrophils; Hypotension; Clinical suspicion of infection; Inadequate organ perfusion or organ dysfunction as demonstrated by: Acute deterioration in mental acuity (excluding sedatives or other nonsepsis causes) OR Unexplained metabolic acidosis OR Oliguria for greater than 2 hours OR Unexplained coagulopathy (elevated PT or PTT or platelet count decreased to less than 50% of baseline within 24 hours or less than 100,000/mm3) OR Acute elevation of bilirubin to greater than 2.0 mg/dL AND elevation of alkaline phosphatase, SGOT, or SGPT
- •No sepsis with unstable BP
- •-Prior/Concurrent Therapy--
- •At least 30 days since prior enrollment in investigational trial; No other concurrent enrollment in investigational trial
- •-Patient Characteristics--
- •Hematopoietic: See Disease Characteristics; No uncontrolled hemorrhage (transfusion of 4 or more units required within past 24 hours); No chemotherapy induced neutropenia (granulocyte count less than 1000/mm3)
- •Hepatic: No severe liver disease with portal hypertension
- •Renal: No anuria (urine output less than 50 mL/day)
- •Cardiovascular: No cardiogenic shock
- •Neurologic: No recent stroke, head trauma, or increased intracranial pressure; No other serious neurologic disorder
- •Other: Not pregnant; No acquired immune deficiency syndrome; No immunosuppressed transplant patients; No severe burns; No irreversible underlying condition with rapidly fatal course; No marked obesity; No recent history of diarrhea
排除标准
- 未提供
研究者
研究点 (2)
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