Fluid Responsiveness Prediction at the Bedside

This study has been completed.
Sponsor:
Information provided by:
Fondazione Poliambulanza Istituto Ospedaliero
ClinicalTrials.gov Identifier:
NCT00721604
First received: July 22, 2008
Last updated: July 31, 2009
Last verified: July 2009

July 22, 2008
July 31, 2009
July 2008
April 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00721604 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • estimation of variables independently associated to arterial pressure increase [ Time Frame: one hour after the end of fluid administration ] [ Designated as safety issue: No ]
  • estimation of variables independently associated to clinically relevant improvement [ Time Frame: one hour after the end of fluid administration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Hypotension
  • Shock
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 Name: Haes Steril, Fresenius Kabi
1
patients with mean arterial pressure lower than 65 mmHg
Intervention: Drug: fluid administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00721604
FP-TIP-03
No
Natalini Giuseppe, FPoliambulanza
Fondazione Poliambulanza Istituto Ospedaliero
Not Provided
Principal Investigator: Giuseppe Natalini, MD Fondazione Poliambulanza Istituto Ospedaliero
Fondazione Poliambulanza Istituto Ospedaliero
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP