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Completed

NCT Number: NCT00721604

Fluid Responsiveness Prediction at the Bedside

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

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Key information

Conditions

Hypotension Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid administration

Drug

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

Primary outcomes

  1. 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

    Time frame: one hour after the end of fluid administration

Secondary outcomes

  1. 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

    Time frame: one hour after the end of fluid administration

  2. area under ROC curve of pulse pressure variation before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement

    Time frame: one hour after the end of fluid administration

  3. area under ROC curve of pulse plethysmographic variation before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement

    Time frame: one hour after the end of fluid administration

  4. 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

    Time frame: one hour after the end of fluid administration

  5. area under ROC curve of central venous pressure before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement

    Time frame: one hour after the end of fluid administration

  6. area under ROC curve of central venous saturation before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement

    Time frame: one hour after the end of fluid administration

  7. 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

    Time frame: one hour after the end of fluid administration

  8. area under ROC curve of arterial lactate before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement

    Time frame: one hour after the end of fluid administration

  9. area under ROC curve of fractional excretion of sodium before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement

    Time frame: one hour after the end of fluid administration

  10. area under ROC curve of sodium/potassium urinary ratio before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement

    Time frame: one hour after the end of fluid administration

  11. comparison between the number of patients with criteria for pulse pressure variation calculation and the number of patients with other predictive variables

    Time frame: one hour after the end of fluid administration

  12. estimation of variables independently associated to arterial pressure increase

    Time frame: one hour after the end of fluid administration

  13. estimation of variables independently associated to clinically relevant improvement

    Time frame: one hour after the end of fluid administration

Sponsors and collaborators

Lead sponsor

Fondazione Poliambulanza Istituto Ospedaliero

Other

Registry information

Official study title

Prediction of Volume Expansion Effectiveness in Hypotensive Critically Ill Patients.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 24, 2008
Registry last updated
Aug 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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