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Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality (DECATSepsis)

Primary Purpose

Septic Shock, Sepsis

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Dexmedetomidine

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring dexmedetomidine, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult (≥ 18 years) patients of either sex who develop septic shock with heart rate (HR) > 90 beats per minute (bpm).

We choose the definition of septic shock as the start of norepinephrine (NE) infusion to maintain the mean arterial blood pressure (MAP) of ≥ 65 mmHg in a case of sepsis (≥ 2 SIRS criteria plus suspicion or confirmation of infection).

Exclusion Criteria:

Patient refusal or inability to obtain consent
Failure of hemodynamic stabilization or hemoglobin < 7 gm/dl at time of inclusion
Severe cardiac dysfunction (Ejection Fraction (EF) < 30%)
History of heart block or patient on pacemaker
Chronic liver Disease (Child-Pugh classification C)
Severe valvular heart disease
Pregnancy

Sites / Locations

Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dexmedetomidine

Usual care without dexmedetomidine infusion

Arm Description

Patients will receive dexmedetomidine infusion according to the protocol plus the usual care. We will evaluate patients for inclusion in the study after 6 hours on NE infusion, given stabilization of the MAP > 65 mmHg. In the DEX group, we will commence DEX infusion at the rate of 0.2 mcg.kg-1.h-1 without a loading dose, then titrate DEX infusion to maintain the HR from 60 to 90 bpm. Titration of the DEX infusion rate will not be more than 0.1 mcg.kg-1.h-1 every 30 minutes at any time. The maximum DEX infusion rate will be 0.7 mcg.kg-1.h-1. We aim to continue DEX infusion for 48 hours. After 48 hours of DEX infusion, we will taper the DEX infusion over one hour. According to our protocol, DEX infusion would trigger either STOP events or hemodynamic assessment events:

The patients in this group will receive the usual care.

Outcomes

Primary Outcome Measures

In-hospital mortality

The investigators will review the patient status on discharge from the hospital, alive or dead

Secondary Outcome Measures

Norepinephrine equivalent dose (NED)

reported as the average of the serial measurements; the NED of epinephrine will be estimated as 1:1 ratio, reported as mcg/kg/min (Shruti Goradia et al, 2021)

Need for epinephrine infusion

Categorical variable (as yes/no outcome)

Heart rate (HR) beat per minute

reported as the average of the serial measurements

Mean arterial blood pressure (MAP) mmHg

reported as the average of the serial measurements

Initiation of invasive mechanical ventilation (IMV) in non-ventilated patients

Categorical variable (as yes/no outcome)

Early acute kidney injury

Categorical variable (as yes/no outcome) - as defined by Khwaja, A., 2012. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clinical Practice, 120(4), pp.c179-c184.

Late acute kidney injury

Categorical variable (as yes/no outcome) - as defined by the Khwaja, A., 2012. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clinical Practice, 120(4), pp.c179-c184.

Full Information

NCT ID

NCT05283083

First Posted

February 28, 2022

Last Updated

May 3, 2023

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT05283083

Brief Title

Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality

Acronym

DECATSepsis

Official Title

Decatecholaminisation With Dexmedetomidine for Reduction of Mortality in Septic Shock: A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

March 25, 2022 (Actual)

Primary Completion Date

February 1, 2023 (Actual)

Study Completion Date

March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study aims to determine whether the infusion of DEX in septic shock can reduce in-hospital mortality, norepinephrine infusion, need and duration for mechanical ventilation, and acute kidney injury without significant adverse events.

Detailed Description

During septic shock, acute stress response includes neural and humoral autonomic flaring, which tend to be beneficial in the short term. Once shock occurs, it is a failure of the compensation trial. In addition, chronic autonomic stimulation risks myocardial injury, immunosuppression, insulin resistance, and thrombo-embolic tendency. The investigators hypothesized that dacatecholaminisation with dexmedetomidine - as calibrated by heart rate control - would reduce the in-hospital mortality in septic shock, whether the patient is mechanically ventilated or not. The study aims to determine whether the infusion of DEX in septic shock can reduce in-hospital mortality, norepinephrine infusion, need and duration for mechanical ventilation, and acute kidney injury without significant adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock, Sepsis

Keywords

dexmedetomidine, randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

An open label randomized controlled trial

Masking

None (Open Label)

Masking Description

There is no masking

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine

Arm Type

Experimental

Arm Description

Arm Title

Usual care without dexmedetomidine infusion

Arm Type

No Intervention

Arm Description

The patients in this group will receive the usual care.

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

Precedex, Dexdor, Dexdomitor, Sileo

Intervention Description

A highly-selective alpha-2 agonist with sedative, analgesic, and sympatholytic effects.

Primary Outcome Measure Information:

Title

In-hospital mortality

Description

The investigators will review the patient status on discharge from the hospital, alive or dead

Time Frame

Through study completion, an average of 3 months

Secondary Outcome Measure Information:

Title

Norepinephrine equivalent dose (NED)

Description

reported as the average of the serial measurements; the NED of epinephrine will be estimated as 1:1 ratio, reported as mcg/kg/min (Shruti Goradia et al, 2021)

Time Frame

over the first 3 days after enrolment or death, which comes first

Title

Need for epinephrine infusion

Description

Categorical variable (as yes/no outcome)

Time Frame

over the first 3 days after enrolment or death, which comes first

Title

Heart rate (HR) beat per minute

Description

reported as the average of the serial measurements

Time Frame

over the first 3 days after enrolment or death, which comes first

Title

Mean arterial blood pressure (MAP) mmHg

Description

reported as the average of the serial measurements

Time Frame

over the first 3 days after enrolment or death, which comes first

Title

Initiation of invasive mechanical ventilation (IMV) in non-ventilated patients

Description

Categorical variable (as yes/no outcome)

Time Frame

Through study completion, an average of 3 months

Title

Early acute kidney injury

Description

Categorical variable (as yes/no outcome) - as defined by Khwaja, A., 2012. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clinical Practice, 120(4), pp.c179-c184.

Time Frame

48 hours after ICU admission in previously normal kidney function

Title

Late acute kidney injury

Description

Categorical variable (as yes/no outcome) - as defined by the Khwaja, A., 2012. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clinical Practice, 120(4), pp.c179-c184.

Time Frame

7 days after ICU admission in previously normal kidney function

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult (≥ 18 years) patients of either sex who develop septic shock with heart rate (HR) > 90 beats per minute (bpm). We choose the definition of septic shock as the start of norepinephrine (NE) infusion to maintain the mean arterial blood pressure (MAP) of ≥ 65 mmHg in a case of sepsis (≥ 2 SIRS criteria plus suspicion or confirmation of infection). Exclusion Criteria: Patient refusal or inability to obtain consent Failure of hemodynamic stabilization or hemoglobin < 7 gm/dl at time of inclusion Severe cardiac dysfunction (Ejection Fraction (EF) < 30%) History of heart block or patient on pacemaker Chronic liver Disease (Child-Pugh classification C) Severe valvular heart disease Pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moataz M Emara, MD, EDAIC

Organizational Affiliation

Mansoura University Faculty of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Mansoura University Hospitals

City

Mansoura

State/Province

Aldakahlia

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The anonymously patient data will be available on reasonable request - according to the local IRB approval - from the corresponding author and the central study contact, Moataz Emara at mm.emara@mans.edu.eg or mm.emara@yahoo.com.

IPD Sharing Time Frame

will be shared shortly.

IPD Sharing Access Criteria

Learn more about this trial

Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality

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