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

NCT06937918 | Recruiting

• 1 other identifier: SI 118/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

To investigate the benefit of using the AFM and Eadyn-guided fluid and vasopressor therapy in septic shock resuscitation for mechanically ventilated patients compared with the standard of care. The investigators hypothesize that using the AFM and Eadyn-guided fluid/vasopressor titration in septic shock patients who underwent mechanical ventilation might reduce the time to shock reversal.

Conditions

Critical Illness; Fluid Over-load; Dynamic Arterial Elastance; Septic Shock

Keywords

critical illness; dynamic arterial elastance; stroke volume change prediction; fluid overload; ischemic complication; septic shock

Outcome Measures

Primary Outcomes (1)

• time to shock reversal

  the time from diagnosis of septic shock until the achievement of sustained MAP of ≥65 mmHg with evidence of adequate tissue perfusion (continuation of urine flow ≥ 0.5 ml/kg/h or normalized or continuing decrease in serum lactate ≥10% from the previous value) without any vasopressor infusion

  28 days

Secondary Outcomes (18)

• a time-to-goal achievement for septic shock resuscitation

  28 days

• time to NE titrating

  48 hours

• maximum dose of vasopressors

  48 hours

• volume of fluid therapy during resuscitation

  48 hours

• fluid before randomization

  48 hours

Other Outcomes (1)

• adverse event

  28 days

Study Arms (2)

the standard of care group

ACTIVE COMPARATOR

The standard of care group will be treated according to according to septic shock guidelines 2021; In brief A vasopressor with optimal ideal fluid (at least 30 ml/kg) will be given to achieve the hemodynamic target (MAP ≥ 65 mm Hg) by fluid challenge technique guided by MAP and central venous pressure (CVP) changes after fluid challenge. Fluid-responsive tests can be used as a subsidiary, depending on the attending physician. Early Norepinephrine (NE) infusion can be used with a standard dose of 0.05 mcg/k/min and titrated at the rate of 0.01-0.02 mcg/kg/min every 10 min until 0.25 mcg/kg/min was achieved; then, the second line vasopressor will be added and adjusted to the target of vasopressor. Hydrocortisone can be given according to septic shock guidelines.

Other: The standard care for septic shock

AFM and Eadyn - guided resuscitation group

EXPERIMENTAL

Patients randomized to this arm are treated with the standard of care for patients with septic shock as described for 'the standard of care' arm, along with the AFM and Eadyn - guided resuscitation group, as detailed under 'Interventions'

Device: The AFM and Eadyn - guided resuscitation group; Other: The standard care for septic shock

Interventions

The AFM and Eadyn - guided resuscitation group DEVICE

A fluid challenge using a stroke volume change prediction (∆SVpredict) and Eadyn guide. If the ∆SVpredict is more than 10%, isotonic crystalloid of 500 ml will be administered in 30 minutes, and the machine's response will be awaited. If ∆SVpredict is still more than 10%, continuous fluid loading was reapplied until SVV was less than 10% (fluid therapy will be stopped if ∆SVpredict is less than 10%) and dynamic arterial elastance (EAdyn) reaches the goal of 0.8-1.0 along with a vasopressor will be administered and titrated every 10 minutes until the target MAP \> 65 mmHg is reached. After MAP of 65 achieved, tissue perfusion including urine output, capillary refill time, and serum lactate will be assessed

Also known as: hemosphere, dynamic arterial elastance

AFM and Eadyn - guided resuscitation group

The standard care for septic shock OTHER

The standard of care group will be treated according to according to septic shock guidelines 2021; In brief A vasopressor with optimal ideal fluid (at least 30 ml/kg) will be given to achieve the hemodynamic target (MAP ≥ 65 mm Hg) by fluid challenge technique guided by MAP and central venous pressure (CVP) changes after fluid challenge. Fluid-responsive tests can be used as a subsidiary, depending on the attending physician. Early Norepinephrine (NE) infusion can be used with a standard dose of 0.05 mcg/k/min and titrated at the rate of 0.01-0.02 mcg/kg/min every 10 min until 0.25 mcg/kg/min was achieved; then, the second line vasopressor will be added and adjusted to the target of vasopressor. Hydrocortisone can be given according to septic shock guidelines. After MAP of 65 achieved, tissue perfusion including urine output, capillary refill time, and serum lactate will be assessed

AFM and Eadyn - guided resuscitation group; the standard of care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Thai consecutive patients older than 18 years with a diagnosis of sepsis or septic shock in medical ICU, defined by clinically suspected or confirmed infection and MAP \<65 mmHg according to the criteria of the Surviving Sepsis Campaign 2021(11)with onset of shock in less than 24 hours.
• Already receiving or planning for mechanical ventilation
• Already receiving or planning for arterial catheter placement for invasive arterial pressure monitoring
• All patients will receive an echocardiogram with a cut point of LVEF \> 30% to be included in the study

You may not qualify if:

• Active, immediate, life-threatening cardiac arrhythmia, defined as ventricular tachycardia and ventricular fibrillation
• Acute cerebral vascular event, including both acute ischemic stroke or intracranial hemorrhage
• Acute coronary syndrome
• cardiogenic shock, acute heart failure
• Severe asthma exacerbation
• Fluid intolerance: hypoxemia (P:F ratio \< 150)
• Life-threatening gastrointestinal hemorrhage
• Pregnancy
• Requirement for immediate surgery within 2 hours of randomization
• Advanced-stage cancer with predicted survival of less than 6 months
• Oliguric AKI with signs of volume overload
• Withdrawal or termination criteria
• The patient and legal representative request for withdrawal
• The attending physician requested a withdrawal

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (3)

Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

NOT YET RECRUITING

Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

Related Publications (15)

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• Maheshwari K, Malhotra G, Bao X, Lahsaei P, Hand WR, Fleming NW, Ramsingh D, Treggiari MM, Sessler DI, Miller TE; Assisted Fluid Management Study Team. Assisted Fluid Management Software Guidance for Intraoperative Fluid Administration. Anesthesiology. 2021 Aug 1;135(2):273-283. doi: 10.1097/ALN.0000000000003790.

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  PMID: 38325215 BACKGROUND

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  PMID: 25598221 BACKGROUND

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  PMID: 34331607 BACKGROUND

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Related Links

• sample size

MeSH Terms

Conditions

Critical Illness; Shock, Septic; Edema

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ranistha Ratanarat, MD

CONTACT

+66 2419 7767; ranittha@gmail.com

Nuwara Pornawalai, MD

CONTACT

+66 2419 7767; nuwara.por@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A fluid challenge using a stroke volume change prediction (∆SVpredict) and Eadyn guide. If the ∆SVpredict is more than 10%, isotonic crystalloid of 500 ml will be administered in 30 minutes, and wait for the response of the machine for 5 minutes after loading. If ∆SVpredict is still more than 10%, continuous fluid loading was reapplied until SVV was less than 10% (fluid therapy will be stopped if ∆SVpredict is less than 10%) and dynamic arterial elastance (EAdyn) reaches the goal of 0.8-1.0\[5\] along with a vasopressor will be administered and titrated every 10 minutes until the target mABP \> 65 mmHg is reached.

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: April 23, 2025
• Primary Completion (Estimated): April 8, 2027
• Study Completion (Estimated): April 8, 2028
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (3)