Clinical trial NCT01333059: Cycling of Sedative Infusions in Critically Ill Pediatric Patients
Official title: A Randomized, Double-blind, Controlled Trial of Cycling Continuous Sedative Infusions in Critically Ill Pediatric Patients Requiring Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Failure
Keywords: Sedation
Cycling
Pediatric
Lead sponsor: Cook Children's Health Care System
Sponsor class: OTHER
First posted: 2011-04-11
Enrollment: 25
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Duration of Mechanical Ventilation Days
timeFrame: From date of randomization until the date of discharge from PICU, assessed up to 1 month
Secondary outcomes:
measure: PICU Length of Stay
timeFrame: From date of randomization until the date of discharge from PICU, assessed up to 1 month
measure: Hospital Length of Stay
timeFrame: From date of hospital admission to date of hospital discharge, assessed up to 6 weeks
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
Study officials:
affiliation: Cook Children's Physician Network
name: Javier Gelvez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cook Children's Physician Network
name: Linda L Thompson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
citation: Kollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous i.v. sedation is associated with prolongation of mechanical ventilation. Chest. 1998 Aug;114(2):541-8. doi: 10.1378/chest.114.2.541.
citation: Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA Jr, Murray MJ, Peruzzi WT, Lumb PD; Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002 Jan;30(1):119-41. doi: 10.1097/00003246-200201000-00020. No abstract available.
citation: Ista E, van Dijk M, Tibboel D, de Hoog M. Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT "behavior" scale. Pediatr Crit Care Med. 2005 Jan;6(1):58-63. doi: 10.1097/01.PCC.0000149318.40279.1A.
citation: van Dijk M, Peters JW, van Deventer P, Tibboel D. The COMFORT Behavior Scale: a tool for assessing pain and sedation in infants. Am J Nurs. 2005 Jan;105(1):33-6. doi: 10.1097/00000446-200501000-00019. No abstract available.
citation: Kress JP, Gehlbach B, Lacy M, Pliskin N, Pohlman AS, Hall JB. The long-term psychological effects of daily sedative interruption on critically ill patients. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1457-61. doi: 10.1164/rccm.200303-455OC. Epub 2003 Oct 2.
citation: Kress JP, Vinayak AG, Levitt J, Schweickert WD, Gehlbach BK, Zimmerman F, Pohlman AS, Hall JB. Daily sedative interruption in mechanically ventilated patients at risk for coronary artery disease. Crit Care Med. 2007 Feb;35(2):365-71. doi: 10.1097/01.CCM.0000254334.46406.B3.
citation: Colville G, Kerry S, Pierce C. Children's factual and delusional memories of intensive care. Am J Respir Crit Care Med. 2008 May 1;177(9):976-82. doi: 10.1164/rccm.200706-857OC. Epub 2008 Jan 31.
citation: Connolly D, McClowry S, Hayman L, Mahony L, Artman M. Posttraumatic stress disorder in children after cardiac surgery. J Pediatr. 2004 Apr;144(4):480-4. doi: 10.1016/j.jpeds.2003.12.048.