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Fluid Responsiveness Prediction at the Bedside

Completed
Conditions
Hypotension
Shock
Interventions
Drug: fluid administration
Registration Number
NCT00721604
Lead Sponsor
Fondazione Poliambulanza Istituto Ospedaliero
Brief Summary

The purpose of this study is to verify the accuracy and applicability of predictors of fluid administration efficacy in hypotensive critically ill patients.

Detailed Description

Severe hypotension is a common life-threatening conditions in critically ill patients. Discriminating between the need for volume expansion or inotropic/vasoactive support is a main clinical goal. Pulse pressure variation are an accurate index of fluid responsiveness, but it needs controlled mechanical ventilation with a tidal volume of at least 8 ml/kg and absence of arrhythmias. This could limit its clinical applicability. Moreover pulse pressure variation accurately predicted cardiac output increment. However the cardiac output increase is not a clinically relevant target in absence of low cardiac output.

The objectives of the present protocol are: 1) to calculate the accuracy of cardiovascular and renal variables to predict either arterial pressure increase or clinically relevant improvement after fluid administration and 2) to verify how often dynamic indices could be applied in clinical practice.

Arterial pressure increase is defined by mean arterial pressure above 65 mmHg or an increment greater than 20 % respect to basal value. Clinically relevant improvement is defined by restoring adequate values of arterial pressure or cardiac index or diuresis or central venous saturation if they are inadequate before fluid administration. These adequate values are 65 mmHg for mean arterial pressure, 2.5 l.min-1.m-2 for cardiac index, 0.5 ml.kg-1.h-1 for the diuresis, 70 % for central venous saturation.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria
  • mean arterial pressure lower than 65 mmHg
Exclusion Criteria
  • fluid overload
  • mean arterial pressure lower than 45 mmHg and mandatory immediate treatment
  • active bleeding
  • hemoglobin lower than 8 g.dl-1

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
1fluid administrationpatients with mean arterial pressure lower than 65 mmHg
Primary Outcome Measures
NameTimeMethod
area under ROC curve of pulse pressure variation before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressureone hour after the end of fluid administration
Secondary Outcome Measures
NameTimeMethod
area under ROC curve of pulse plethysmographic variation before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressureone hour after the end of fluid administration
area under ROC curve of pulse pressure variation before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvementone hour after the end of fluid administration
area under ROC curve of pulse plethysmographic variation before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvementone hour after the end of fluid administration
area under ROC curve of central venous pressure before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressureone hour after the end of fluid administration
area under ROC curve of central venous pressure before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvementone hour after the end of fluid administration
area under ROC curve of central venous saturation before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvementone hour after the end of fluid administration
area under ROC curve of central-arterial PCO2 pressure difference before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvementone hour after the end of fluid administration
area under ROC curve of arterial lactate before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvementone hour after the end of fluid administration
area under ROC curve of fractional excretion of sodium before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvementone hour after the end of fluid administration
area under ROC curve of sodium/potassium urinary ratio before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvementone hour after the end of fluid administration
comparison between the number of patients with criteria for pulse pressure variation calculation and the number of patients with other predictive variablesone hour after the end of fluid administration
estimation of variables independently associated to arterial pressure increaseone hour after the end of fluid administration
estimation of variables independently associated to clinically relevant improvementone hour after the end of fluid administration

Trial Locations

Locations (1)

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero

🇮🇹

Brescia, Italy

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero
🇮🇹Brescia, Italy

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