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NCT Number: NCT05283083

Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mansoura University Hospitals

Al Mansurah, Aldakahlia, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Precedex, Dexdor, Dexdomitor, Sileo

Primary outcomes

  1. In-hospital mortality

    Time frame: Through study completion, an average of 3 months

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

Secondary outcomes

  1. Norepinephrine equivalent dose (NED)

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

    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)

  2. Need for epinephrine infusion

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

    Categorical variable (as yes/no outcome)

  3. Heart rate (HR) beat per minute

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

    reported as the average of the serial measurements

  4. Mean arterial blood pressure (MAP) mmHg

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

    reported as the average of the serial measurements

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

    Time frame: Through study completion, an average of 3 months

    Categorical variable (as yes/no outcome)

  6. Early acute kidney injury

    Time frame: 48 hours after ICU admission in previously normal kidney function

    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.

  7. Late acute kidney injury

    Time frame: 7 days after ICU admission in previously normal kidney function

    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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: DECATSepsis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2022
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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