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NCT Number: NCT06839404

Pharmacodynamic Analysis of the HaemOdynamic Effects of a Standard Fluid BolUS

When the flow of blood ejected by the heart drops significantly, that is to say when there is "shock", one of the first treatments undertaken is often volume expansion. This treatment consists of injecting a liquid intravenously, generally in the form of a bolus, that is to say a dose of solute administered all at once, of 250 to 500 mL of fluid over approximately 10 to 30 minutes. The injected fluid expands the blood volume and fills the heart pump, in order to increase the flow it ejects.

However, this treatment poses two problems. First, it is only inconsistently effective. It is possible that of the 250-500 mL of fluid administered in the standard way, only a part is effective, whereas, as the effectiveness decreases during the infusion, the rest does not increase cardiac output significantly.

However, the average part of the total volume that is ineffective on a large population of patients is not well known.

Second, the effects of volume expansion on cardiac output decrease rapidly after the end of administration. However, the average duration of effectiveness of a 250-500 mL fluid bolus, and the factors that influence this duration of effectiveness, are not well determined.

The main objective of this research is to measure, among the volume of a fluid bolus, which part does not significantly increase cardiac output. The secondary objective is to measure the average time of effectiveness after the end of the infusion and the factors that influence it.

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Key information

Conditions

Shock Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bicêtre Hospital

Le Kremlin-Bicêtre, 94320, France

Location status: Recruiting

Location contact

Xavier Monnet, MD, PhD

CONTACT

[email protected]

+33660862669

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years old
  • Hospitalisation in intensive care
  • Haemodynamic monitoring already in place with a pulse wave contour analysis-derived estimation of cardiac output (either calibrated or uncalibrated)
  • Decision taken by the clinicians in charge of the patient to perform volume expansion by intravenous infusion of a 6 mL/kg crystalloid bolus

Exclusion criteria

  • Pregnancy
  • Refusal to participate by relatives of the patient or the patient himself
  • Other therapeutic modification during volume expansion

Treatment and study plan

fluid challenge

Drug

Fluid bolus of 500 mL of crystalloids given at a constant rate between 10 and 15 minutes

Primary outcomes

  1. To measure, during the administration of a fluid bolus in order to perform volume expansion, the volume of fluid which causes an increase in cardiac output of less than 15%.

    Time frame: During the fluid bolus administration (<15min)

    We will measure, among the volume administered (500mL), the proportion of infused volume which allowed an increase in cardiac output ≥15% compared to the baseline value. This baseline value will be defined by the average measured over the minute preceding the start of the fluid infusion

Secondary outcomes

  1. The maximum amplitude of the change induced by volume expansion in cardiac output, mean arterial pressure and central venous pressure

    Time frame: During the fluid bolus administration (<15min)

    The maximum amplitude, expressed as an absolute value and as a percentage of the baseline value, as defined above, of the change induced by volume expansion in cardiac output, mean arterial pressure and central venous pressure

  2. The delay at which this maximum effect appears in terms of cardiac output, mean arterial pressure and central venous pressure

    Time frame: During the fluid bolus administration (<15min)

  3. The time following the end of the infusion from which the cardiac output becomes ≤5% of the baseline value

    Time frame: A period of 120 minutes following the fluid infusion

  4. The factors that influence these pharmacokinetic variables will be determined

    Time frame: During the study period (during fluid administration and the period of 120 minutes following the infusion)

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Lai, MD, PhD

CONTACT

[email protected]

+33 (0)145212671 ext. +33

Xavier Monnet, MD, PhD

CONTACT

[email protected]

+33660862669

Sponsors and collaborators

Lead sponsor

Bicetre Hospital

Other

Registry information

Official study title

Pharmacodynamic Analysis of the HaemOdynamic Effects of a Standard Fluid BolUS - the PHOEBUS Study

Acronym: PHOEBUS

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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