NCT00405847

Brief Summary

The purpose of this study is to assess the short-term effect of sympatholysis on sleep quality and inflammation in critically ill patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

First QC Date

November 29, 2006

Last Update Submit

October 26, 2016

Conditions

SleepCritical Illness

Keywords

SleepCritical illnessCytokine

Outcome Measures

Primary Outcomes (2)

  • Sleep disruption (Arousals, awakenings and sleep efficiency measured by polysomnography)

  • Circulating levels of Inflammatory cytokines (TNF-alpha, IL-1, IL-6, IL-10)

Interventions

DexmedetomidineDRUG

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring mechanical ventilation with a diagnosis of
  • Acute Respiratory Distress Syndrome
  • Cardiogenic Pulmonary Edema
  • Pneumonia
  • Chronic obstructive pulmonary disease

You may not qualify if:

  • Patients who are considered too unstable to undergo this investigation by their primary physician
  • Comatose patients, or patients with severe debilitating neurological disease
  • Renal insufficiency (Sr. Creatinine \> 2 mg/dL)
  • Heart block (second or third degree heart block) or sinus bradycardia (heart rate \< 60 beats per minute)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Arizona VA Healthcare System

Tucson, Arizona, 85723, United States

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sairam Parthasarathy, MD

    SAVAHCS and University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2006

First Posted

November 30, 2006

Study Start

July 1, 2006

Study Completion

May 1, 2007

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

US(1)