SepsisPhase 4NCT01397474
Peripheral Perfusion Targeted Fluid Management
A Phase 4 study testing PPTFM in people with Sepsis and Severe Sepsis, run by Erasmus Medical Center at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis, Severe Sepsis
- What is being tested?
- PPTFM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesNetherlands
- Study dates
- Oct 2011to Jan 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- moribund.
- severe coagulation disorder (contraindication for central venous catheter placement).
- severe peripheral vascular disease (interfering with peripheral perfusion measurement).
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
ErasmusMC
Rotterdam, South Holland, 3015 CE Rotterdam
Jasper van Bommel, MD,PhD, 0031107040704, j.vanbommel@erasmusmc.nl
Jasper van Bommel, MD, PhD
- Recruiting
ErasmusMC
Rotterdam, South Holland, 3015 CE Rotterdam
Jasper v Bommel, MD,PhD, j.vanbommel@erasmusmc.nl
Jasper v Bommel, MD,PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Sepsis, Severe Sepsis
- Being tested
- PPTFM
- Keywords
- peripheral perfusion, critically ill patients, fluid administration
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPTFMOther
Also called CRT, PFI, delta Temp, StO2
Peripheral Perfusion Targeted Fluid Management
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PPTFM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid balance during Intensive Care Unit stay
Total and daily fuid balance for a maximal time period of 72 hours
Measured: untill 72 hours after admission
Secondary outcomes (6)
CRT (Capillary refill time)
Parameter of peripheral perfusion
Measured: Within 72 hours after admission
Systemic hemodynamic variables
- Heart Rate
- Mean Arterial Pressure
- Cardiac Index
- Cardiac output
- Stroke Volume
- Central Venous Pressure
- Systemic Vascular Resistance
Measured: Untill 72 hours after admission to the ICU
Respiratory function
- FiO2
- PEEP
- Breathing Frequency
- pCO2
- pO2
Measured: Untill 72 hours after admission to the ICU
PFI (Peripheral Flow Index)
Parameter of peripheral perfusion
Measured: Untill 72 hours after ICU admission
Tskindiff (Forearm-to-Fingertip temperature skin difference)
Parameter of peripheral perfusion
Measured: Untill 72 hours after ICU admission
StO2 (Peripheral tissue oxygenation)
Parameter of peripheral perfusion
Measured: Untill 72 hours after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ME van Genderen, Erasmus Medical Center
- Investigators
- Jasper van Bommel, MD, PhD, Study director, Erasmus Medical CenterMichel E Genderen, Drs, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397474
- Sponsor's protocol ID
- NL34607.078.10
- Status last verified
- Jan 2014
- First submitted
- 7 Jul 2011
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19237899Lima 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.
PubMed 21685739van 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.
PubMed 25679107
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Perfusion Targeted Fluid Management in Critically Ill Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT01397474
- Acronym / sponsor ID
- NL34607.078.10
- Conditions
- Sepsis, Severe Sepsis
- Keywords
- peripheral perfusion, critically ill patients, fluid administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: PPTFMThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- moribund.
- severe coagulation disorder (contraindication for central venous catheter placement).
- severe peripheral vascular disease (interfering with peripheral perfusion measurement).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPTFMAlso: CRT, PFI, delta Temp, StO2Peripheral Perfusion Targeted Fluid Management | Other | PPTFM |
Primary outcome
Fluid balance during Intensive Care Unit stay
Time frame: untill 72 hours after admission
Total and daily fuid balance for a maximal time period of 72 hours
6 secondary outcomes
CRT (Capillary refill time)
Time frame: Within 72 hours after admission
Systemic hemodynamic variables
Time frame: Untill 72 hours after admission to the ICU
Respiratory function
Time frame: Untill 72 hours after admission to the ICU
PFI (Peripheral Flow Index)
Time frame: Untill 72 hours after ICU admission
Tskindiff (Forearm-to-Fingertip temperature skin difference)
Time frame: Untill 72 hours after ICU admission
StO2 (Peripheral tissue oxygenation)
Time frame: Untill 72 hours after ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
- Background: PubMed 19237899Lima 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.
- Background: PubMed 21685739Lima 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.
- Derived from this study: PubMed 25679107van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasper van Bommel, MD, PhD study director
Erasmus Medical Center
Michel E Genderen, Drs principal investigator
Erasmus Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PPTFM in people with Sepsis and Severe Sepsis, run by Erasmus Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jasper Bommel, MD, PhD (003110704 0704, j.vanbommel@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid balance during Intensive Care Unit stay (time frame: untill 72 hours after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01397474, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2014.