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Dynamic response to fluid challenge administration in operating room: a pilot trial.

Dynamic response to fluid challenge administration in operating room: a pilot trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001479493
Enrollment
50
Registered
2016-10-24
Start date
2014-12-01
Completion date
2015-12-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background: Assessing preload dependence by means of static and dynamic indexes of fluid responsiveness is limited to a minority of critically ill and surgical patients. The lack in the sensitivity and specificity of these indexes in revealing fluid responsiveness before fluid challenge (FC) administration increases the risk of fluid overloading. Since, in responders and non-responders, the FC causes different hemodynamic effects in cardiac function and peripheral tone the outcome could be predicted before the entire infusion by dynamically assessing these variables. Methods: 50 patients scheduled for elective abdominal surgery. The FC was administered to improve an episode of hemodynamic instability, and consisted in 500 ml of crystalloids in 10 minutes. A bivariate logistic regression mode was constructed to predict the outcome of the FC including baseline pulse pressure variation (PPV), and four different cardiovascular indexes provided by the MostCare. Design: prospective multicentric study

Interventions

Fluid challenge consisting in 500 ml of intravenous crystalloids (both saline 0,9% or Ringer Acetate or Lactate were allowed), administered in 10 minutes. The Fluid challenge is administered by the attending physician to correct hemodynamic instability during the surgical procedure (see also eligibility). All the patients received hemodynamic monitoring with the MostCare system which provides all the hemodynamic variables evaluated in the study before and after fluid challenge administration (ca

Fluid challenge consisting in 500 ml of intravenous crystalloids (both saline 0,9% or Ringer Acetate or Lactate were allowed), administered in 10 minutes. The Fluid challenge is administered by the attending physician to correct hemodynamic instability during the surgical procedure (see also eligibility). All the patients received hemodynamic monitoring with the MostCare system which provides all the hemodynamic variables evaluated in the study before and after fluid challenge administration (cardiac output, stroke volume, arterial elastance, cardiac cycle efficiency) All patients will receive an echocardiographic assessment before and after the FC including, tissue doppler waveforms (both right and left ventricle), mitral pattern assessment (includine E/e'; E/A waves analysis), Velocity time integral of aortic flow pattern (VTI) and VTI variations

Sponsors

Antonio Messina
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1) to have > or = 18 years 2) to be scheduled for elective open abdominal surgery under general anesthesia with mechanical ventilation with a volume controlled mode (with a tidal volume (VT) < 8 ml/kg), 3) to require an invasive blood pressure monitoring.

Exclusion criteria

1) the American Society of Anesthesiologists' physical status classification (ASA) equal to 4, 2) presence of a previous history of arrhythmia, or left ventricular ejection fraction < 30%, or right ventricular dysfunction (assessed by a < 0.16 m/s of systolic peak velocity of tricuspid annular motion), or a moderate to severe valvular heart disease , or intra-cardiac shunt, 3) chronic medication with beta-blockers.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 26, 2026