Respiratory FailureNCT01333059
Cycling of Sedative Infusions in Critically Ill Pediatric Patients
A study testing Midazolam, Normal saline and Fentanyl in people with Respiratory Failure, run by Javier Gelvez, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Midazolam, Normal saline and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cook Children's Medical Center
Fort Worth, Texas, 76104
About this study
Official title: A Randomized, Double-blind, Controlled Trial of Cycling Continuous Sedative Infusions in Critically Ill Pediatric Patients Requiring Mechanical Ventilation
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.
Read the 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.
- Conditions
- Respiratory Failure
- Keywords
- Sedation, Cycling, Pediatric
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Versed, Study Drug M
Normal salineDrug
Also called Placebo
FentanylDrug
Also called Subsys, Duragesic, Abstral, Lazanda, IONSYS, Study Drug F
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Midazolam; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization until the date of discharge from PICU, assessed up to 1 month
Secondary outcomes (2)
PICU Length of Stay
Participants will be followed for an expected average of 7 days. This secondary endpoint is to be evaluated every six months.
Measured: From date of randomization until the date of discharge from PICU, assessed up to 1 month
Hospital Length of Stay
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.
Measured: From date of hospital admission to date of hospital discharge, assessed up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startSep 2010
- Primary completionOct 2012
- Study completionJan 2013
Why it stopped: Unable to adequately enroll over a reasonable enrollment period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javier Gelvez, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Javier Gelvez, MD, Cook Children's Health Care System
- Investigators
- Javier Gelvez, MD, Principal investigator, Cook Children's Physician NetworkLinda L Thompson, MD, Principal investigator, Cook Children's Physician Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333059
- Sponsor's protocol ID
- Sedation Cycling
- Status last verified
- Jan 2019
- First submitted
- 6 Apr 2011
- Last updated
- 15 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 10816184Kollef 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.
PubMed 9726743Jacobi 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.
PubMed 11902253Ista 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.
PubMed 15636661van 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.
PubMed 15659992Kress 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.
PubMed 14525802Kress 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.
PubMed 17205005Colville 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.
PubMed 18244955Connolly 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.
PubMed 15069396
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled Trial of Cycling Continuous Sedative Infusions in Critically Ill Pediatric Patients Requiring Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01333059
- Acronym / sponsor ID
- Sedation Cycling
- Conditions
- Respiratory Failure
- Keywords
- Sedation, Cycling, Pediatric
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to adequately enroll over a reasonable enrollment period.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Javier Gelvez, MDUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Apr 2011 (estimated)
- Results
- Posted 23 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Midazolam, Drug: Normal saline, Drug: FentanylIn 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 |
| Control Group | Active comparator | Drug: Midazolam, Drug: FentanylIn 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamAlso: Versed, Study Drug M | Drug | Control Group, Experimental Group |
| Normal salineAlso: Placebo | Drug | Experimental Group |
| FentanylAlso: Subsys, Duragesic, Abstral, Lazanda, IONSYS, Study Drug F | Drug | Control Group, Experimental Group |
Primary outcome
Duration of Mechanical Ventilation Days
Time frame: From date of randomization until the date of discharge from PICU, assessed up to 1 month
Participants will be followed for an expected average of 4 days. The Data Safety Monitoring Group will review the data every 6 months.
2 secondary outcomes
PICU Length of Stay
Time frame: From date of randomization until the date of discharge from PICU, assessed up to 1 month
Hospital Length of Stay
Time frame: From date of hospital admission to date of hospital discharge, assessed up to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10816184Kress 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.
- Background: PubMed 9726743Kollef 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.
- Background: PubMed 11902253Jacobi 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.
- Background: PubMed 15636661Ista 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.
- Background: PubMed 15659992van 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.
- Background: PubMed 14525802Kress 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.
- Background: PubMed 17205005Kress 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.
- Background: PubMed 18244955Colville 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.
- Background: PubMed 15069396Connolly 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.
- 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 ventilationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Gelvez, MD principal investigator
Cook Children's Physician Network
Linda L Thompson, MD principal investigator
Cook Children's Physician Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam, Normal saline and Fentanyl in people with Respiratory Failure, run by Javier Gelvez, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Mechanical Ventilation Days (time frame: From date of randomization until the date of discharge from PICU, assessed up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01333059, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.