NCT01938079

Brief Summary

In a healthy patient, the lungs provide oxygen to the blood and remove carbon dioxide. However, in patients with severe lung failure, blood may not adequately be delivered to the lungs, or the lungs may not adequately supply blood with oxygen. In this case, patients may require assistance from a machine to help provide this oxygen. Extracorporeal membrane oxygenation (ECMO) is a device that acts as an artificial lung, allowing the patient to recover from their illness. Patients receiving support from ECMO are often put in a medically induced coma while their lungs heal. Certain drugs may stick to the internal surfaces of the machine; therefore leading to decreased concentrations. Patients receiving ECMO often require high doses of both pain medications and sedatives in order to provide comfort. Low doses of a drug, ketamine, may help to provide additive effects to pain relief and allow lower doses of other pain medications. The hypothesis is that patients treated with continuous intravenous ketamine, will have lower requirements of other pain medications while receiving ECMO for acute respiratory failure while achieving the desired level of sedation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

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

September 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 29, 2016

Completed
Last Updated

September 29, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

September 5, 2013

Results QC Date

August 5, 2016

Last Update Submit

August 5, 2016

Conditions

Acute Respiratory Failure

Keywords

ECMOKetamineOpiatesLung failureExtracorporeal membrane oxygenationMechanical ventilationSedation

Outcome Measures

Primary Outcomes (1)

  • Cumulative Fentanyl Equivalents From ECMO Initiation to Decision to Achieve Wakefulness

    Culmulative fentanyl equivalents meaning the combination of sedative drug regimen - measured in mg - from ECMO initiation to decision to achieve wakefulness.

    Up to 14 days

Study Arms (2)

Sedative without Ketamine

ACTIVE COMPARATOR

Subjects will receive sedative drug regimen without Ketamine.

Other: Sedative drug regimen

Sedative with Ketamine

EXPERIMENTAL

Subjects will receive sedative drug regimen with Ketamine.

Drug: KetamineOther: Sedative drug regimen

Interventions

KetamineDRUG

Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.

Also known as: Ketalar
Sedative with Ketamine
Sedative drug regimenOTHER

(Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation.

Sedative with KetamineSedative without Ketamine

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving ECMO for acute respiratory failure
  • Requiring deep sedation (RASS -5)

You may not qualify if:

  • Allergy to ketamine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NewYork-Presbyterian Hospital

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

KetamineHypnotics and Sedatives

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic Uses

Results Point of Contact

Title
Amy L. Dzierba, Pharm.D., BCPS, BCCCP, FCCM
Organization
Columbia University
ald9012@nyp.org
212-305-5852

Study Officials

  • Daniel Brodie, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 10, 2013

Study Start

September 1, 2013

Primary Completion

February 1, 2015

Study Completion

August 1, 2015

Last Updated

September 29, 2016

Results First Posted

September 29, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)