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
  Purpose
  • 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.

Condition Intervention Phase
Sepsis
Severe Sepsis
Other: PPTFM
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Peripheral Perfusion Targeted Fluid Management in Critically Ill Patients: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: PPTFM
Peripheral Perfusion Targeted Fluid Management
Other Names:
  • CRT
  • PFI
  • delta Temp
  • StO2

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  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: NCT01397474

Contacts
Contact: Jasper Bommel, MD, PhD 003110704 0704 j.vanbommel@erasmusmc.nl

Locations
Netherlands
ErasmusMC Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 CE Rotterdam
Contact: Jasper van Bommel, MD,PhD    0031107040704    j.vanbommel@erasmusmc.nl   
Principal Investigator: Jasper van Bommel, MD, PhD         
Sub-Investigator: Alex P Lima, MD         
Sub-Investigator: Michel E van Genderen, Drs         
Sub-Investigator: Sophie Nebout, MD         
ErasmusMC Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 CE Rotterdam
Contact: Jasper v Bommel, MD,PhD       j.vanbommel@erasmusmc.nl   
Principal Investigator: Jasper v Bommel, MD,PhD         
Sub-Investigator: Michel v Genderen, Msc         
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Study Director: Jasper van Bommel, MD, PhD Erasmus MC
Principal Investigator: Michel E Genderen, Drs Erasmus MC
  More Information

Publications:
Responsible Party: ME van Genderen, Drs, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01397474     History of Changes
Other Study ID Numbers: NL34607.078.10
Study First Received: July 7, 2011
Last Updated: January 3, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Erasmus Medical Center:
peripheral perfusion
critically ill patients
fluid administration

Additional relevant MeSH terms:
Critical Illness
Sepsis
Toxemia
Disease Attributes
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on July 29, 2014