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Pulse Pressure Variation Helps to Predict Fluid Responsiveness in Patients Ventilated With Low Tidal Volumes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01569308
First received: March 14, 2012
Last updated: April 2, 2012
Last verified: March 2012
History of Changes
  Purpose

Objective: To determine the value of pulse pressure variation (ΔRESPPP) to predict fluid responsiveness in patients ventilated with low tidal volumes (VT), and to investigate whether a lower ΔRESPPP cut-off point should be used when patients are ventilated with low tidal volumes.

Methods: This cross-sectional, observational study included 37 critically ill patients with acute circulatory failure requiring fluid challenge. They were sedated and mechanically ventilated with Tidal Volume (VT) 6-7 ml/kg IBW (ideal body weight), monitored by pulmonary artery catheter and arterial line. Mechanical ventilation and hemodynamic parameters, including ΔRESPPP, were measured before and after fluid challenge with 1,000 ml crystalloids or 500 ml colloids. Fluid responsiveness was defined as an increase of at least 15% in cardiac index.

The present study was designed to (1) determine the value of ΔRESPPP to predict fluid responsiveness in patients ventilated with low tidal volumes, and (2) to investigate whether a lower ΔRESPPP cut-off point should be used when patients are ventilated with low tidal volumes.

The study hypothesis is not a good predictor of fluid responsiveness in patients ventilated with low tidal volumes.


Condition
Hemodynamic Instability

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pulse Pressure Variation Helps to Predict Fluid Responsiveness in Patients Ventilated With Low Tidal Volumes

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Increase in cardiac index at least 15% of baseline value. [ Time Frame: Cardiac index was measured at the end of a 30 minutes fluid challenge. ] [ Designated as safety issue: No ]
    Patients were sedated and ventilated in controlled pressure or controlled volume mode (Servo I system v.12 or Servo 900 C, Siemens, Sweden) with VT < 8 ml/kg ideal body weight. Ventilatory and hemodynamic variables were measured before and after FC with the patients in a supine position. Fluid challenge was performed with 1000 ml 0.9% saline solution or lactated Ringer's solution or 500 ml hydroxy-ethyl-starch solution 6% 130/0.4 for 30 minutes. The increase in cardiac index was measured immediately after fluid challenge.


Secondary Outcome Measures:
  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Patients were followed for 28 days or until ICU discharge


Enrollment: 38
Study Start Date: May 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients age ≥ 16 years, from both genders, admitted to the HCPA ICU, receiving invasive mechanical ventilation, with hemodynamic instability defined as need for norepinephrine infusion and/or intravascular fluid administration to maintain systolic arterial blood pressure > 90 mm Hg; with arterial line in place (radial or femoral) and pulmonary arterial catheter in place.

Criteria

Inclusion Criteria:

  • Age ≥ 16 years
  • Hemodynamic instability defined as need for norepinephrine infusion and/or intravascular fluid administration to maintain systolic arterial blood pressure > 90 mm Hg
  • Arterial line in place (radial or femoral)
  • Pulmonary arterial catheter in place

Exclusion Criteria:

  • Presence of cardiac arrhythmias
  • Presence of pneumothorax
  • Presence of heart valve disease or intracardiac shunt
  • Previously diagnosed right ventricular insufficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569308

Locations
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Gilberto Friedman Hospital de Clinicas de Porto Alegre
  More Information

No publications provided by Hospital de Clinicas de Porto Alegre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01569308     History of Changes
Other Study ID Numbers: 06-109
Study First Received: March 14, 2012
Last Updated: April 2, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Cardiac output
Pulse pressure variation
Fluid responsiveness
Low tidal volume

ClinicalTrials.gov processed this record on May 23, 2013