Fluid Responsiveness Prediction at the Bedside

Prediction of Volume Expansion Effectiveness in Hypotensive Critically Ill Patients.

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

Study Overview

• Status: Completed
• Conditions: Shock; Hypotension
• Intervention / Treatment: Drug: fluid administration

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy, 25124
    • Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hypotensive patients in a General Intensive Care Unit of a University-affiliated hospital. Patients can be recruited only if they have both arterial and central venous catheters

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; patients with mean arterial pressure lower than 65 mmHg	Drug: fluid administration; two consecutive infusions of 6% hydroxyethyl starch at the dosage 7 ml/kg over 30 minutes (total 14 ml/kg in 60 minutes); Other Names: Haes Steril, Fresenius Kabi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
area under ROC curve of pulse pressure variation before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressure	one hour after the end of fluid administration

Secondary Outcome Measures

Outcome Measure	Time Frame
area under ROC curve of pulse plethysmographic variation before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressure	one 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 improvement	one 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 improvement	one 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 pressure	one 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 improvement	one 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 improvement	one 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 improvement	one 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 improvement	one 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 improvement	one 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 improvement	one 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 variables	one hour after the end of fluid administration
estimation of variables independently associated to arterial pressure increase	one hour after the end of fluid administration
estimation of variables independently associated to clinically relevant improvement	one hour after the end of fluid administration

Collaborators and Investigators

• Sponsor: Fondazione Poliambulanza Istituto Ospedaliero

Publications and helpful links

General Publications

• Natalini G, Rosano A, Militano CR, Di Maio A, Ferretti P, Bertelli M, de Giuli F, Bernardini A. Prediction of arterial pressure increase after fluid challenge. BMC Anesthesiol. 2012 Mar 5;12:3. doi: 10.1186/1471-2253-12-3.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: July 22, 2008
• First Submitted That Met QC Criteria: July 22, 2008
• First Posted (Estimate): July 24, 2008

Study Record Updates

• Last Update Posted (Estimate): August 3, 2009
• Last Update Submitted That Met QC Criteria: July 31, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: shock; fluid responsiveness; volume expansion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Plasma Substitutes; Blood Substitutes; Hydroxyethyl Starch Derivatives
• Other Study ID Numbers: FP-TIP-03