Recruiting

Observational Study

Sponsor:

CentraCare

Code:

NCT06390423

Conditions

Fluid Responsiveness

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Passive leg raise, SVI via bioreactance, Echo based VTI

Study Details

Brief summary:

In the critically ill population, fluid administration in an unstable patient is perhaps the most common intervention that is performed. Uncorrected hypovolemia with inappropriate vasopressors lead to organ hypoperfusion where as overzealous fluid administration especially in ARDS (Adult respiratory distress syndrome) can increase mortality. It has been estimated that only 50% of hemodynamically unstable critically ill patients are volume responsive, hence dynamic assessment of preload responsiveness has been proposed to better identify those individuals who would benefit from fluid bolus.

Conditions

Fluid Responsiveness

Study ID

NCT06390423

Start date

Jul 1, 2023

Status verified date

Aug, 2024

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age between 30 - 90 years
  • Diagnosis of Vasodilatory Shock with no other obvious cause of hypotension
  • Diagnosis of ARDS with PF ratio < 150 , PEEP > 8
  • Patients who are under paralysis or deeply sedated, on a mechanical ventilator

Exclusion Criteria:

  • Patients with arrhythmias including atrial fibrillation
  • Patients with chest tube, intra-abdominal hypertension or with its risk factors
  • Patients with structural heart disease including pulmonary hypertension (RVSP > 45) and heart failure
  • Patients on extracorporeal support such as ECMO, CRRT or MCS.
  • Patients with COPD with a premorbid FEV1 < 1.5 L
  • Severe atherosclerotic vascular disease

Study Design

Enrollment

64 participants

Anticipated

Interventions and Outcome Measures

Arms

Fluid responder

Stability of vasopressor dose with maximum of 500 cc of crystalloids

Fluid non responder

Escalating dose of vasopressors despite 1 L of crystalloid fluid challenge

Interventions

Passive leg raise, SVI via bioreactance, Echo based VTI

No interventions other than fluid challenge

Primary outcome measure

  • Vasopressor dose in Nor-epinephrine equivalents (NE) measured as mcg/kg/min [ Time Frame: 3 hours after the initial passive leg raise ]

Central Contacts and Locations

Central contacts

Ramakanth Pata

320-240-2207cookybrey1@gmail.com

Locations

St Cloud Hospital

Recruiting

Saint Cloud, Minnesota, United States, 56303

Contacts

Ramakanth Pata, MD FCCP

320-240-2207cookybrey1@gmail.com

More Information

Sponsor

CentraCare

Last update posted

Aug 22, 2024

Last verified

Aug, 2024

Keywords

  • Pre-load responsiveness
  • Passive leg raise
  • Mini-fluid challenge

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CentraCare on 2024-08-22.