Dexmedetomidine and Vasopressin in Septic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2026-01-31

Brief Summary

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Rudiger and Singer suggested strategies for refining adrenergic stress (decatecholaminization). They proposed the use of dexmedetomidine and vasopressin to reduce the catecholamine load during sepsis. The investigators will use vasopressin as the primary vasopressor and a heart rate-calibrated dexmedetomidine infusion in septic shock patients.

The investigators of the current study will use DEXPRESSIN in septic shock patients to investigate the effects of decatecholaminization on in-hospital mortality.

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Detailed Description

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The investigator will include 260 patients with septic shock. The study will compare the use of vasopressin as the first-line vasopressor in septic shock in addition to the dexmedetomidine infusion as in the DecatSepsis trial versus the standard of care. The standard of care is guided by the Surviving Sepsis campaign in 2021.

The main outcomes of the study are in-hospital mortality, norepinephrine equivalent dose, ICU scores, and inflammatory markers.

Conditions

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Sepsis Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled superiority trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The outcome assessor will be nurses - not invovled in the study - will be unware about the study drug.

Study Groups

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DEX-PRESSIN

This group will receive vasopressin as the first-line vasopressor. DEX will be started after hemodynamic stabilization if the heart rate is \>90 beats per minute (bpm). NE infusion will be the second-line vasoactive drug.

Group Type EXPERIMENTAL

DEX-PRESSIN

Intervention Type DRUG

This group will receive vasopressin as the first-line vasopressor. DEX will be started after hemodynamic stabilization if the heart rate is \>90 beats per minute (bpm). NE infusion will be the second-line vasoactive drug.

Standard-of-care group

This group will receive conventional treatment according to the Surviving Sepsis Campaign 2021 guidelines. This group will receive vasopressin as the second line after NE and will not receive dexmedetomidine.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type DRUG

This group will receive conventional treatment according to the SSC 2021 guidelines. This group will receive vasopressin as the second line after NE and will not receive DEX.

Interventions

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DEX-PRESSIN

This group will receive vasopressin as the first-line vasopressor. DEX will be started after hemodynamic stabilization if the heart rate is \>90 beats per minute (bpm). NE infusion will be the second-line vasoactive drug.

Intervention Type DRUG

Standard of Care

This group will receive conventional treatment according to the SSC 2021 guidelines. This group will receive vasopressin as the second line after NE and will not receive DEX.

Intervention Type DRUG

Other Intervention Names

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Control group

Eligibility Criteria

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Inclusion Criteria

* Adult patients who develop septic shock in whom a vasopressor is initiated to maintain a mean arterial blood pressure (MAP) of ≥65 mmHg in the presence 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 g/dL at the time of inclusion
* Severe cardiac dysfunction \[i.e., ejection fraction (EF) \<30%\]
* History of heart block or patient on pacemaker
* Severe valvular heart disease
* Chronic liver disease (Child-Pugh classification C)
* Pregnancy
* Patients with traumatic brain injury

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No