Peripheral Perfusion Targeted Fluid Management

NCT01397474 | Unknown Phase 4 DMC

• 1 other identifier: NL34607.078.10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Sepsis; Severe Sepsis

Keywords

peripheral perfusion; critically ill patients; fluid administration

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• CRT (Capillary refill time)

  Within 72 hours after admission

• Systemic hemodynamic variables

  Untill 72 hours after admission to the ICU

• Respiratory function

  Untill 72 hours after admission to the ICU

• PFI (Peripheral Flow Index)

  Untill 72 hours after ICU admission

• Tskindiff (Forearm-to-Fingertip temperature skin difference)

  Untill 72 hours after ICU admission

Study Arms (2)

Control

NO INTERVENTION

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.

PPTFM

EXPERIMENTAL

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

Interventions

PPTFM OTHER

Peripheral Perfusion Targeted Fluid Management

Also known as: CRT, PFI, delta Temp, StO2

PPTFM

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• moribund.
• severe coagulation disorder (contraindication for central venous catheter placement).
• severe peripheral vascular disease (interfering with peripheral perfusion measurement).

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (2)

ErasmusMC

Rotterdam, South Holland, 3015 CE Rotterdam, Netherlands

RECRUITING

ErasmusMC

Rotterdam, South Holland, 3015 CE Rotterdam, Netherlands

RECRUITING

Related Publications (3)

• 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.

  PMID: 19237899 BACKGROUND

• 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.

  PMID: 21685739 BACKGROUND

• van Genderen ME, Engels N, van der Valk RJ, Lima A, Klijn E, Bakker J, van Bommel J. Early peripheral perfusion-guided fluid therapy in patients with septic shock. Am J Respir Crit Care Med. 2015 Feb 15;191(4):477-80. doi: 10.1164/rccm.201408-1575LE. No abstract available.

  PMID: 25679107 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jasper van Bommel, MD, PhD

  Erasmus Medical Center

  STUDY DIRECTOR

• Michel E Genderen, Drs

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasper Bommel, MD, PhD

CONTACT

003110704 0704; j.vanbommel@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Drs

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 19, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 6, 2014

Record last verified: 2014-01

Locations

NL (2)