Peripheral Perfusion Targeted Fluid Management

Sepsis Clinical Trial

Official title:

Peripheral Perfusion Targeted Fluid Management in Critically Ill Patients: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01397474
• Other study ID #: NL34607.078.10
• Status: Recruiting
• Phase: Phase 4
• First received: July 7, 2011
• Last updated: January 3, 2014
• Start date: October 2011
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Erasmus Medical Center
• Contact: Jasper Bommel, MD, PhD
• Phone: 003110704 0704
• Email: j.vanbommel[@]erasmusmc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

• 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis

Intervention

Other:
• PPTFM
Peripheral Perfusion Targeted Fluid Management

Locations

Country	Name	City	State
Netherlands	ErasmusMC	Rotterdam	Zuid-Holland
Netherlands	ErasmusMC	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Lima A, Jansen TC, van Bommel J, Ince C, Bakker J. The prognostic value of the subjective assessment of peripheral perfusion in critically ill patients. Crit Care Med. 2009 Mar;37(3):934-8. doi: 10.1097/CCM.0b013e31819869db. — View Citation

Lima A, van Bommel J, Sikorska K, van Genderen M, Klijn E, Lesaffre E, Ince C, Bakker J. The relation of near-infrared spectroscopy with changes in peripheral circulation in critically ill patients. Crit Care Med. 2011 Jul;39(7):1649-54. doi: 10.1097/CCM.0b013e3182186675. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid balance during Intensive Care Unit stay	Total and daily fuid balance for a maximal time period of 72 hours	untill 72 hours after admission	No
Secondary	CRT (Capillary refill time)	Parameter of peripheral perfusion	Within 72 hours after admission	No
Secondary	Systemic hemodynamic variables	Heart Rate; Mean Arterial Pressure; Cardiac Index; Cardiac output; Stroke Volume; Central Venous Pressure; Systemic Vascular Resistance	Untill 72 hours after admission to the ICU	No
Secondary	Respiratory function	FiO2; PEEP; Breathing Frequency; pCO2; pO2	Untill 72 hours after admission to the ICU	No
Secondary	PFI (Peripheral Flow Index)	Parameter of peripheral perfusion	Untill 72 hours after ICU admission	No
Secondary	Tskindiff (Forearm-to-Fingertip temperature skin difference)	Parameter of peripheral perfusion	Untill 72 hours after ICU admission	No
Secondary	StO2 (Peripheral tissue oxygenation)	Parameter of peripheral perfusion	Untill 72 hours after ICU admission	No