Fluid Responsiveness Prediction at the Bedside

Hypotension Clinical Trial

Official title:

Prediction of Volume Expansion Effectiveness in Hypotensive Critically Ill Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721604
• Other study ID #: FP-TIP-03
• Status: Completed
• Phase: N/A
• First received: July 22, 2008
• Last updated: July 31, 2009
• Start date: July 2008
• Est. completion date: May 2009

Study information

• Verified date: July 2009
• Source: Fondazione Poliambulanza Istituto Ospedaliero
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypotension
• Shock

Intervention

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)

Locations

Country	Name	City	State
Italy	Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Poliambulanza Istituto Ospedaliero

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	estimation of variables independently associated to arterial pressure increase		one hour after the end of fluid administration	No
Secondary	estimation of variables independently associated to clinically relevant improvement		one hour after the end of fluid administration	No