NCT03477344

Brief Summary

We designed a prospective, double blind, randomized, controlled versus placebo study to evaluate the efficacy of nightly low dose of Dexmedetomidine infusion to promote sleep and lower delirium in a population of post cardiac surgery patients. This population is characterized by longer ICU stay, more physical restraints such as catheters and drains, pain and sleep deprivation. It is associated with higher prevalence of Delirium and agitation leading to exposure to severe agitation related adverse events.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
348

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

9 active sites

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

First Submitted

Initial submission to the registry

March 6, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

January 4, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2021

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

2.5 years

First QC Date

March 6, 2018

Last Update Submit

June 21, 2022

Conditions

ICU Delirium

Keywords

Cardiac SurgeryDeliriumSleep deprivation

Outcome Measures

Primary Outcomes (1)

  • Delirium

    Occurrence of delirium diagnosed by the Confusion Assessment Method (CAM ICU) at any time in the first seven days after surgery

    7 days

Secondary Outcomes (15)

  • agitation with be assessed using the Richmond agitation and sedation score

    7 days

  • length of ICU stay

    28 days

  • length of hospital stay

    28 days

  • quality of life 3 months after surgery with the The Short Form (36) Health Survey score

    90 days

  • cognitive capacity 3 months after surgery evaluated with the Cognitive Failures Questionnnaire (CFQ)

    90 days

  • +10 more secondary outcomes

Study Arms (2)

Dexmédétomidine

ACTIVE COMPARATOR

Intravenous infusion with electric syringe of Dexmedetomidine 0,4ug/ml. Rate 0,1ug/kg/h to 1,4ug/kg/h. Nightly infusion from 20:00 to 08:00. The drug is titrated to achieve RASS between -1 and 1. Modification of infusion rate by 0,1ug/kg/h is recommended with stabilization phase of 1 hour before another rate adjustment.

Drug: Dexmedetomidine

Sodium Chloride 0,9%

PLACEBO COMPARATOR

Intravenous infusion with electric syringe of normal saline. Rate modifications follow the same rules as in experimental group.

Drug: Sodium chloride 0.9%

Interventions

DexmedetomidineDRUG

Intravenous infusion with electric syringe of Dexmedetomidine 0,4ug/ml. Rate 0,1ug/kg/h to 1,4ug/kg/h. Nightly infusion from 20:00 to 08:00. The drug is titrated to achieve RASS between -1 and 1. Modification of infusion rate by 0,1ug/kg/h is recommended with stabilization phase of 1 hour before another rate adjustment.

Dexmédétomidine
Sodium chloride 0.9%DRUG

Intravenous infusion with electric syringe of normal saline. Rate modifications follow the same rules as in experimental group.

Sodium Chloride 0,9%

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • patients aged 65 or more who undergo cardiac surgery on and off-pump: coronary artery bypass graft, cardiac valve replacement or both.
  • Consent signed

You may not qualify if:

  • history of mental illness, dementia
  • length of stay in ICU less than 24 hours
  • alpha 2 agonists allergy
  • surgery performed in an immediate emergency situation
  • uncontrolled hypotension
  • second and third degree atrioventricular block without pacemaker
  • severe hepatic insufficiency
  • acute cerebrovascular diseases
  • patient treated with clonidine
  • patient with disturbed preoperative liver assessment (hepatocellular insufficiency)
  • patient under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Angers university hospital

Angers, France

Location

CHRU de Brest

Brest, 29609, France

Location

Clermont Ferrand university hospital

Clermont-Ferrand, France

Location

CHU de Grenoble

Grenoble, 38000, France

Location

Hôpital Privé Jacques Cartier

Massy, France

Location

CHU de Nantes

Nantes, 5600, France

Location

CHU la Pitié Salpétrière

Paris, 75000, France

Location

CHU Poitiers

Poitiers, 86000, France

Location

CHU de Rennes

Rennes, 22000, France

Location

Related Publications (2)

  • Huet O, Gargadennec T, Oilleau JF, Rozec B, Nesseler N, Bougle A, Kerforne T, Lasocki S, Eljezi V, Dessertaine G, Amour J, Chapalain X; EXACTUM and the Atlanrea Study Group. Prevention of post-operative delirium using an overnight infusion of dexmedetomidine in patients undergoing cardiac surgery: a pragmatic, randomized, double-blind, placebo-controlled trial. Crit Care. 2024 Feb 29;28(1):64. doi: 10.1186/s13054-024-04842-1.

    PMID: 38419119DERIVED

  • Gargadennec T, Oilleau JF, Rozec B, Nesseler N, Lasocki S, Futier E, Amour J, Durand M, Bougle A, Kerforne T, Consigny M, Eddi D, Huet O. Dexmedetomidine after Cardiac Surgery for Prevention of Delirium (EXACTUM) trial protocol: a multicentre randomised, double-blind, placebo-controlled trial. BMJ Open. 2022 Apr 8;12(4):e058968. doi: 10.1136/bmjopen-2021-058968.

    PMID: 35396310DERIVED

MeSH Terms

Conditions

DeliriumSleep Deprivation

Interventions

DexmedetomidineSodium Chloride

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersDyssomniasSleep Wake Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 26, 2018

Study Start

January 4, 2019

Primary Completion

June 29, 2021

Study Completion

June 29, 2021

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning five years and ending fifteen years following the final study report completion
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR(9)