Fluid Responsiveness Prediction at the Bedside

NCT ID: NCT00721604

Last Updated: 2009-08-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-05-31

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.

Conditions

Hypotension; Shock

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

1

patients with mean arterial pressure lower than 65 mmHg

fluid administration

Intervention Type: DRUG

two consecutive infusions of 6% hydroxyethyl starch at the dosage 7 ml/kg over 30 minutes (total 14 ml/kg in 60 minutes)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

Haes Steril, Fresenius Kabi

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Poliambulanza Istituto Ospedaliero

OTHER

Sponsor Role: lead

Responsible Party

FPoliambulanza

Principal Investigators

Giuseppe Natalini, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Poliambulanza Istituto Ospedaliero

Locations

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero

Brescia, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 22390818 (View on PubMed)

Other Identifiers

FP-TIP-03

Identifier Type: -

Identifier Source: org_study_id