Cycling of Sedative Infusions in Critically Ill Pediatric Patients

NCT01333059 | Terminated Results DMC

• 1 other identifier: Sedation Cycling
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure

Keywords

Sedation; Cycling; Pediatric

Outcome Measures

Primary Outcomes (1)

• Duration of Mechanical Ventilation Days

  Participants will be followed for an expected average of 4 days. The Data Safety Monitoring Group will review the data every 6 months.

  From date of randomization until the date of discharge from PICU, assessed up to 1 month

Secondary Outcomes (2)

• PICU Length of Stay

  From date of randomization until the date of discharge from PICU, assessed up to 1 month

• Hospital Length of Stay

  From date of hospital admission to date of hospital discharge, assessed up to 6 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling. At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each. Dosing was done per standard of care and not prescribed per protocol

Drug: Midazolam; Drug: Normal saline; Drug: Fentanyl

Control Group

ACTIVE COMPARATOR

In this arm, midazolam and fentanyl were administered during cycling. At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each. Dosing was done per standard of care and not prescribed per protocol.

Drug: Midazolam; Drug: Fentanyl

Interventions

Midazolam DRUG

Also known as: Versed, Study Drug M

Control Group; Experimental Group

Normal saline DRUG

Also known as: Placebo

Experimental Group

Fentanyl DRUG

Also known as: Subsys, Duragesic, Abstral, Lazanda, IONSYS, Study Drug F

Control Group; Experimental Group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Javier Gelvez, MD: lead

Study Sites (1)

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Related Publications (9)

• 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.

  PMID: 10816184 BACKGROUND

• 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.

  PMID: 9726743 BACKGROUND

• 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.

  PMID: 11902253 BACKGROUND

• 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.

  PMID: 15636661 BACKGROUND

• 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.

  PMID: 15659992 BACKGROUND

• 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.

  PMID: 14525802 BACKGROUND

• 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.

  PMID: 17205005 BACKGROUND

• 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.

  PMID: 18244955 BACKGROUND

• 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.

  PMID: 15069396 BACKGROUND

Related Links

• Click here for more information about this study: A randomized, double-blind, controlled trial of cycling continuous sedative infusions in critically ill pediatric patients requiring mechanical ventilation

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Midazolam; Saline Solution; Fentanyl

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Piperidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Javier Gelvez, MD
• Organization: Cook Children's Medical Center

Javier.Gelvez@cookchildrens.org

Study Officials

• Javier Gelvez, MD

  Cook Children's Physician Network

  PRINCIPAL INVESTIGATOR

• Linda L Thompson, MD

  Cook Children's Physician Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 11, 2011
• Study Start: September 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2013
• Last Updated: January 15, 2019
• Results First Posted: November 23, 2018

Record last verified: 2019-01

Locations

US (1)