Peripheral Perfusion Targeted Fluid Management

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Erasmus Medical Center
Sponsor:
Information provided by (Responsible Party):
ME van Genderen, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01397474
First received: July 7, 2011
Last updated: January 3, 2014
Last verified: January 2014

July 7, 2011
January 3, 2014
October 2011
January 2014   (final data collection date for primary outcome measure)
Fluid balance during Intensive Care Unit stay [ Time Frame: untill 72 hours after admission ] [ Designated as safety issue: No ]
Total and daily fuid balance for a maximal time period of 72 hours
Same as current
Complete list of historical versions of study NCT01397474 on ClinicalTrials.gov Archive Site
  • CRT (Capillary refill time) [ Time Frame: Within 72 hours after admission ] [ Designated as safety issue: No ]
    Parameter of peripheral perfusion
  • Systemic hemodynamic variables [ Time Frame: Untill 72 hours after admission to the ICU ] [ Designated as safety issue: No ]
    • Heart Rate
    • Mean Arterial Pressure
    • Cardiac Index
    • Cardiac output
    • Stroke Volume
    • Central Venous Pressure
    • Systemic Vascular Resistance
  • Respiratory function [ Time Frame: Untill 72 hours after admission to the ICU ] [ Designated as safety issue: No ]
    • FiO2
    • PEEP
    • Breathing Frequency
    • pCO2
    • pO2
  • PFI (Peripheral Flow Index) [ Time Frame: Untill 72 hours after ICU admission ] [ Designated as safety issue: No ]
    Parameter of peripheral perfusion
  • Tskindiff (Forearm-to-Fingertip temperature skin difference) [ Time Frame: Untill 72 hours after ICU admission ] [ Designated as safety issue: No ]
    Parameter of peripheral perfusion
  • StO2 (Peripheral tissue oxygenation) [ Time Frame: Untill 72 hours after ICU admission ] [ Designated as safety issue: No ]
    Parameter of peripheral perfusion
Same as current
Not Provided
Not Provided
 
Peripheral Perfusion Targeted Fluid Management
Peripheral Perfusion Targeted Fluid Management in Critically Ill Patients: a Pilot Study
  • Impaired peripheral perfusion is related to worse outcome in critically ill patients. Although this is known, these parameters have never been used as target for hemodynamic therapy.
  • We hypothesize that targeting of fluid administration on parameters of peripheral perfusion might prevent excessive fluid administration, leading to less formation of tissue edema, less respiratory dysfunction and shorter duration of mechanical ventilation in critically ill patients.

Rationale: Currently, fluid administration of critically ill patients is aimed at optimizing conventional hemodynamic parameters such as stroke volume and cardiac output. Fluid is infused repeatedly until patients become "non-responsive", i.e. cardiac output does not increase anymore. However, the ultimate goal of hemodynamic therapy should be to improve peripheral (i.e. tissue) perfusion. Recently we have shown that 1) increasing stroke volume does not always have an effect on peripheral perfusion and 2) that peripheral perfusion is not impaired when stroke volume can still be increased with fluid infusion. Furthermore, repeated administration of fluid in order to reach a maximum cardiac output can lead to an enormous accumulation of fluid in the patient. This leads to formation of lung edema and respiratory dysfunction and is associated with prolonged mechanical ventilation and ICU-stay. Recently, techniques have been developed which allow bedside assessment of peripheral perfusion. Although impaired peripheral perfusion was related to worse outcome, these parameters have never been used as target for hemodynamic therapy.

Objective: To study whether peripheral perfusion targeted fluid management (PPTFM) leads to less fluid administration, improved respiratory function and shorter mechanical ventilation.

Study design: The study is a pilot study and is designed as a randomized controlled trial. The study will be conducted as a single-center study at the Intensive Care of the Erasmus Medical Center.

Study population: We aim to include 40 adult patients who are admitted to the Intensive Care with hemodynamic instability (defined as mean arterial pressure < 65 mmHg and an arterial lactate concentration > 3.0 mmol/l) due to severe sepsis and septic shock.

Intervention: In the intervention group fluid management is targeted on peripheral perfusion parameters while in the control group fluid is administered in order to optimize cardiac output.

Main study parameters/endpoints: The main study endpoints are daily fluid balance and duration of mechanical ventilation.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is a possible risk that in the treatment group the patients will remain hypovolemic. To ensure that this will not occur, fluids will be administrated in this group, irrespective of peripheral perfusion parameters, until cardiac index is 2,5 L/min/m2. Assessment of peripheral perfusion is performed with non-invasive optical techniques that impose no burden to the patient.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • Sepsis
  • Severe Sepsis
Other: PPTFM
Peripheral Perfusion Targeted Fluid Management
Other Names:
  • CRT
  • PFI
  • delta Temp
  • StO2
  • No Intervention: Control
    The fluid management algorithm of the control group is based on the standard care procedure of our ICU as recommended in guidelines: the patient's fluid status is assessed by performing a fluid challenge with a bolus of 250 ml colloids. When the patients is fluid responsive (i.e. showing an increase in stroke volume > 10% ) he will receive an additional bolus of 250 ml of colloids. After each fluid challenge, patients will be revaluated for fluid responsiveness to access need of further fluid administration.
  • Experimental: PPTFM
    The fluid management algorithm of the intervention group uses identical therapy (i.e. fluids) yet targeted at different endpoints (i.e. peripheral perfusion parameters). After evaluation of peripheral perfusion, only patients with a "bad peripheral perfusion" (i.e. 3 out of 4 criteria considered as bad) will receive a fluid challenge, the same way as in the standard care procedure (i.e. bolus of 250 ml of fluid). After each fluid challenge, patients will be re-evaluated for peripheral perfusion to access further need in fluid challenges. To ensure that no hypovolemia will occur in the intervention group, fluid will be administered irrespectively of peripheral perfusion parameters, if cardiac index falls below a value of 2,5 L/min/m2.
    Intervention: Other: PPTFM

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All adult patients (>18 years) admitted to the intensive care with 1) hemodynamic instability due to severe sepsis, and 2) a mean arterial pressure < 65 mmHg and 3) an arterial lactate concentration > 3.0 mmol/L will be considered for participation

Exclusion Criteria:

  • moribund.
  • severe coagulation disorder (contraindication for central venous catheter placement).
  • severe peripheral vascular disease (interfering with peripheral perfusion measurement).
Both
18 Years to 85 Years
No
Contact: Jasper Bommel, MD, PhD 003110704 0704 j.vanbommel@erasmusmc.nl
Netherlands
 
NCT01397474
NL34607.078.10
Yes
ME van Genderen, Erasmus Medical Center
Erasmus Medical Center
Not Provided
Study Director: Jasper van Bommel, MD, PhD Erasmus MC
Principal Investigator: Michel E Genderen, Drs Erasmus MC
Erasmus Medical Center
January 2014

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