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
  Purpose

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


Condition Intervention
Hypotension
Shock
Drug: fluid administration

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prediction of Volume Expansion Effectiveness in Hypotensive Critically Ill Patients.

Resource links provided by NLM:


Further study details as provided by Fondazione Poliambulanza Istituto Ospedaliero:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: July 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Haes Steril, Fresenius Kabi

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721604

Locations
Italy
Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy, 25124
Sponsors and Collaborators
Fondazione Poliambulanza Istituto Ospedaliero
Investigators
Principal Investigator: Giuseppe Natalini, MD Fondazione Poliambulanza Istituto Ospedaliero
  More Information

No publications provided

Responsible Party: Natalini Giuseppe, FPoliambulanza
ClinicalTrials.gov Identifier: NCT00721604     History of Changes
Other Study ID Numbers: FP-TIP-03
Study First Received: July 22, 2008
Last Updated: July 31, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione Poliambulanza Istituto Ospedaliero:
shock
fluid responsiveness
volume expansion

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014