Cycling of Sedative Infusions in Critically Ill Pediatric Patients

This study has been terminated.
(Unable to adequately enroll over a reasonable enrollment period.)
Sponsor:
Information provided by (Responsible Party):
Javier Gelvez, MD, Cook Children's Health Care System
ClinicalTrials.gov Identifier:
NCT01333059
First received: April 6, 2011
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to determine if the reduction of the total amount of sedative critically pediatric ill patients receive in the PICU will achieve a significant decrease in mechanical ventilation days and a decrease in the overall length of stay in the PICU and hospital.


Condition Intervention
Respiratory Failure
Drug: Midazolam/Fentanyl
Drug: Sedative Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Controlled Trial of Cycling Continuous Sedative Infusions in Critically Ill Pediatric Patients Requiring Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by Cook Children's Health Care System:

Primary Outcome Measures:
  • Duration of mechanical ventilation days [ Time Frame: Discharge from PICU ] [ Designated as safety issue: No ]
    Participants will be followed for an expected average of 4 days. The Data Safety Monitoring Group will review the data every 6 months.


Secondary Outcome Measures:
  • PICU length of stay [ Time Frame: Discharge from PICU ] [ Designated as safety issue: No ]
    Participants will be followed for an expected average of 7 days. This secondary endpoint is to be evaluated every six months.

  • Hospital length of stay [ Time Frame: Discharge from hospital ] [ Designated as safety issue: No ]
    Participants will be followed for an expected average of 7 days in PICU and 10 days of hospitalization. This secondary endpoint is to be evaluated every six months.


Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sedative control
At cycling time for midazolam, the continuous infusion of midazolam will be stopped by the bedside nurse. The nurse will start a pump containing a syringe labeled "Study Drug M" which will contain the control drug (midazolam). The switch to Study Drug M will occur twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl will be stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which will contain the control drug (fentanyl), will be started. The switch to Study Drug F will occur twice daily at 1400 and 0200 for a period of 3 hours each.
Drug: Midazolam/Fentanyl
Sedative Control
Drug: Sedative Intervention
Intervention arm - Fentanyl and Midazolam will be replaced with placebo
Placebo Comparator: Sedative Intervention
At cycling time for midazolam, the continuous infusion of midazolam will be stopped by the bedside nurse. The nurse will start a pump containing a syringe labeled "Study Drug M" which will contain the placebo drug (normal saline). The switch to Study Drug M will occur twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl will be stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which will contain the placebo drug (normal saline), will be started. The switch Study Drug F will occur twice daily at 1400 and 0200 for a period of 3 hours each.
Drug: Midazolam/Fentanyl
Sedative Control
Drug: Sedative Intervention
Intervention arm - Fentanyl and Midazolam will be replaced with placebo

Detailed Description:

Continuous sedative infusions have been associated with longer duration of mechanical ventilation, longer stay in the intensive care unit (PICU) and total hospital stay. Also, extended duration of continuous sedative infusions limits the ability to assess for adequate neurologic function.

There is, however, no published data on the use of daily interruption of continuous sedative infusions in pediatric patients, nor are there any recommendations from the leading pediatric critical care groups regarding this issue. Infants and children exposed to noxious stimuli (endotracheal tube, endotracheal suctioning, mechanical ventilation, indwelling catheters) in addition to an unknown environment are less likely to cooperate during normal daily interventions in the PICU. Continuous infusions of benzodiazepines and opioids in addition to as needed (PRN) bolus doses have been the standard of care in our institution for mechanically ventilated patients.

The study seeks to determine if reducing the total dose of sedatives, by holding them in a cyclical manner, will be a safe and effective intervention that will not increase adverse patient outcomes. This will be achieved by limiting the patient tolerance to the sedatives, decreasing the body total deposit of sedatives and subsequently decreases awakening time when patient is ready for extubation.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Less than or equal to 18 years of age
  • Intubated and mechanically ventilated
  • Expected to require continuous infusions of sedatives for at least 48 hours
  • Parent or legal guardian available for informed consent
  • Males and females of any race are eligible

Exclusion Criteria:

  • Less than 72 hours after surgery
  • Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
  • Critical airway (according to PICU Attending)
  • Ventilator dependent (including noninvasive) on PICU admission
  • Greater than 48 hours of continuous sedation infusion(s)
  • Neuromuscular respiratory failure
  • Managed by patient controlled analgesia (PCA) or epidural catheter
  • Known allergy to any of the study medications (fentanyl or midazolam)
  • Family/Medical team have decided not to provide full support (patient treatment considered futile)
  • Patient requires ECMO
  • Head trauma requiring intracranial pressure monitoring
  • Pregnancy
  • Following resuscitation from cardiorespiratory arrest whose initial pH is < 6.9
  • ICU Attending judgment that patient should be excluded for safety reasons
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333059

Locations
United States, Texas
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
Javier Gelvez, MD
Investigators
Principal Investigator: Javier Gelvez, MD Cook Children's Physician Network
Principal Investigator: Linda L Thompson, MD Cook Children's Physician Network
  More Information

Additional Information:
Publications:

Responsible Party: Javier Gelvez, MD, M.D., Cook Children's Health Care System
ClinicalTrials.gov Identifier: NCT01333059     History of Changes
Other Study ID Numbers: Sedation Cycling
Study First Received: April 6, 2011
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cook Children's Health Care System:
Sedation
Cycling
Pediatric

Additional relevant MeSH terms:
Critical Illness
Respiratory Insufficiency
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Fentanyl
Hypnotics and Sedatives
Midazolam
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Molecular Mechanisms of Pharmacological Action
Narcotics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014