Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06937918

Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Adjustment of Vasopressor and Fluid Therapy in Septic Shock Resuscitation; A Pilot Study

Led by Mahidol University · Updated on 2025-04-27

60

Participants Needed

3

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the benefit of using dynamic arterial elastance (Eadyn) and Assisted Fluid Management (AFM) software to guide fluid and vasopressor therapy in patients with septic shock who are mechanically ventilated. Septic shock involves systemic inflammation causing low blood pressure and organ dysfunction, and managing fluids and vasopressors precisely is challenging. This pilot study compares the AFM and Eadyn-guided therapy to the standard care approach to see if it can reduce the time it takes for shock to reverse. The study has two groups: one receiving standard care based on septic shock guidelines including vasopressors like norepinephrine and fluid challenges guided by blood pressure and central venous pressure; the other group receives standard care plus AFM and Eadyn-guided treatment. This involves using a monitoring device to measure stroke volume changes and arterial elastance to guide fluid administration and vasopressor dosing every 10 minutes until blood pressure targets are met. Fluid therapy is adjusted based on specific predictions and arterial tone measurements. Participants will be assessed through invasive arterial pressure monitoring, echocardiograms, and clinical measures such as urine output, capillary refill time, and serum lactate levels. Researchers will track outcomes including time to shock reversal within 28 days, vasopressor dose and duration, fluid volume given, hospital length of stay, mortality, and kidney function measures. Safety and effectiveness data will be collected throughout the trial, which runs until April 2028.

CONDITIONS

Brief Title

Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of sepsis or septic shock with low blood pressure (MAP < 65 mmHg) within 24 hours
  • Receiving or planning to receive mechanical ventilation
  • Receiving or planning arterial catheter placement for invasive blood pressure monitoring
  • Left ventricular ejection fraction (LVEF) greater than 30% on echocardiogram
Not Eligible

You will not qualify if you...

  • Life-threatening cardiac arrhythmia such as ventricular tachycardia or ventricular fibrillation
  • Acute cerebral vascular events including ischemic stroke or intracranial hemorrhage
  • Acute coronary syndrome or cardiogenic shock
  • Acute heart failure
  • Severe asthma exacerbation
  • Fluid intolerance with hypoxemia (P:F ratio < 150)
  • Life-threatening gastrointestinal bleeding
  • Pregnancy
  • Need for immediate surgery within 2 hours of randomization
  • Advanced-stage cancer with expected survival less than 6 months
  • Oliguric acute kidney injury with signs of volume overload
  • Withdrawal requested by patient, legal representative, or attending physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 48 hours

Participants receive resuscitation for septic shock either guided by dynamic arterial elastance and assisted fluid management software or by the standard care according to septic shock guidelines. Treatment involves fluid therapy and vasopressor adjustments to achieve the target mean arterial pressure (MAP) of 65 mm Hg with continuous monitoring of tissue perfusion.

Continuous monitoring during ICU stay with frequent assessments

Follow-up

Duration - Up to 28 days

Participants are monitored for clinical outcomes including shock reversal, organ function, fluid accumulation, and survival for up to 28 days after treatment.

Assessments at multiple time points during hospital and ICU stay

Trial Site Locations

Total: 3 locations

1

Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, Thailand, 10700

Not Yet Recruiting

2

Siriraj Hospital, Mahidol University

Bangkok, Thailand, 10700

Actively Recruiting

3

Siriraj Hospital, Mahidol University

Bangkok, Thailand, 10700

Actively Recruiting

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Research Team

R

Ranistha Ratanarat, MD

N

Nuwara Pornawalai, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Frequently Asked Questions

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