Passive Leg Raise and Mini-fluid Challenge Effect on Various Cardiac Output Surrogates for Fluid Responsiveness

NCT06390423 | Recruiting

• 1 other identifier: RAMPHOENIX
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Vasopressor dose in Nor-epinephrine equivalents (NE) measured as mcg/kg/min

  We shall assess the need for vasopressor dose e.g nor-epinephrine dose. If the dose remains constant after fluid bolus until 3 hours, we shall consider them fluid resposive. If the dose requirement goes up despite fluid bolus, we shall label them fluid un-responsive

  3 hours after the initial passive leg raise

Study Arms (2)

Fluid responder

Stability of vasopressor dose with maximum of 500 cc of crystalloids

Diagnostic Test: Passive leg raise, SVI via bioreactance, Echo based VTI

Fluid non responder

Escalating dose of vasopressors despite 1 L of crystalloid fluid challenge

Interventions

Passive leg raise, SVI via bioreactance, Echo based VTI DIAGNOSTIC_TEST

No interventions other than fluid challenge

Fluid responder

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Screening criteria: 1. New onset of hypotension: MAP \< 65 mm HG for \> 5 min 2. Escalation in Nor-epinephrine needs\> 0.03 ug/kg/min 3. High MAP goal Low Urine output \< 0.5ml/kg/hr for \> 2 hours Elevated Lactate \> 4 moles/L Decreased Lactate clearance (\< 40%) 4. Bedside Echo Inc. VTI No obvious Hypovolemia No Low EF or No Pericardial effusion

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CentraCare: lead

Study Sites (1)

St Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

RECRUITING

Related Publications (2)

• Monnet X, Teboul JL. Passive leg raising: five rules, not a drop of fluid! Crit Care. 2015 Jan 14;19(1):18. doi: 10.1186/s13054-014-0708-5. No abstract available.

  PMID: 25658678 BACKGROUND

• Monnet X, Bataille A, Magalhaes E, Barrois J, Le Corre M, Gosset C, Guerin L, Richard C, Teboul JL. End-tidal carbon dioxide is better than arterial pressure for predicting volume responsiveness by the passive leg raising test. Intensive Care Med. 2013 Jan;39(1):93-100. doi: 10.1007/s00134-012-2693-y. Epub 2012 Sep 19.

  PMID: 22990869 BACKGROUND

Study Officials

• Ramakanth Pata, MD FCCP

  Centracare health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramakanth Pata

CONTACT

320-240-2207; cookybrey1@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: July 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)