NCT03104140

Brief Summary

The aim of this work is to compare two protocols (ketamine-fentanyl-midazolam versus thiopental-fentanyl-midazolam) for induction of anesthesia in patients with septic shock aiming to find the most safe protocol with regards to hemodynamic status of patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2017

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

March 29, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

April 12, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2018

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

March 29, 2017

Last Update Submit

July 7, 2018

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

  • Mean arterial pressure

    Mean arterial blood pressure measured by invasive transducer attached to arterial catheter

    30 minutes after induction of anesthesia

Secondary Outcomes (7)

  • cardiac output

    30 minutes after induction of anesthesia

  • stroke volume

    30 minutes after induction of anesthesia

  • heart rate

    30 minutes after induction of anesthesia

  • Serum lactate

    30 minutes after induction of anesthesia

  • total norepinephrine dose

    30 minutes after induction of anesthesia

  • +2 more secondary outcomes

Study Arms (2)

Ketamine group

EXPERIMENTAL

This group of patients will receive: 1 mg/Kg ketamine + 0.5 ug/Kg fentanyl + 0.05 mg/Kg midazolam for induction of anesthesia. Endotracheal tube will be inserted aided by 1 mg/Kg succinyl choline. Patients will undergo surgical procedure to eliminate the source of sepsis e.g. abdominal exploration. Invasive blood pressure monitor will be connected to the patient through an arterial catheter. Electrical velocimetry (cardiometry) device will be connected to the patient to measure cardiac output, stroke volume, and systemic vascular resistance.

Drug: Ketamine

Thiopental group

ACTIVE COMPARATOR

2 mg/Kg thiopental + 0.5 ug/Kg fentanyl + 0.05 mg/Kg midazolam for induction of anesthesia. Endotracheal tube will be inserted aided by 1 mg/Kg succinyl choline. Patients will undergo surgical procedure to eliminate the source of sepsis e.g. abdominal exploration. Invasive blood pressure monitor will be connected to the patient through an arterial catheter. Electrical velocimetry (cardiometry) device will be connected to the patient to measure cardiac output, stroke volume, and systemic vascular resistance.

Drug: Thiopental

Interventions

KetamineDRUG

After fluid resuscitation, patients will receive :1 mg/Kg ketamine + 0.5 ug/Kg fentanyl + 0.05 mg/Kg midazolam for induction of anesthesia

Also known as: Katalar
Ketamine group
ThiopentalDRUG

After fluid resuscitation, patients will receive :2 mg/Kg Thiopental + 0.5 ug/Kg fentanyl + 0.05 mg/Kg midazolam for induction of anesthesia

Also known as: Intraval
Thiopental group

Eligibility Criteria

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

You may qualify if:

  • Sepsis patients with shock index (heart rate divided by systolic blood pressure) \>0.7. or Sepsis patients with norepinephrine infusion.

You may not qualify if:

  • Traumatic brain injury
  • Cerebrovascular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

KetamineThiopental

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsThiobarbituratesBarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ahmed Mukhtar, Professor

    Head of research committee section in anesthesia department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Lecturer of anesthesia and critical care medicine

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 7, 2017

Study Start

April 12, 2017

Primary Completion

April 1, 2018

Study Completion

April 15, 2018

Last Updated

July 10, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)