Fluid ResponsivenessPPI-FRNCT06313671
Plethysmographic Perfusion Index and Fluid Responsiveness
An observational study of Fluid Responsiveness, run by Avicenna Military Hospital at 1 site in Morocco.
Trial summary
The objective of this study is to assess the reliability of the perfusion index to predict fluid responsiveness in patients with acute circulatory failure in intensive care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Responsiveness
- What is being tested?
- Perfusion index
- How many people
- 50 participants
- Where
- 1 siteMorocco
- Study dates
- 10 Feb 2024to 10 Sep 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 and older with acute circulatory failure (ACF). ACF is defined by the presence of signs of tissue hypoperfusion: capillary refill time>5 seconds, mottling, oliguria <0.5 mL/kg/h for more than an hour), altered mental status), blood lactate >2 mmol/L or metabolic acidosis (pH <7.35 or base excess >-5). Arterial hypotension is not necessary for the diagnosis of ACF. It is defined by a systolic blood pressure (SBP) <90 mmHg, a mean arterial pressure (MAP) <65 mmHg, or a drop in SBP ≥40 mmHg. Shock is defined by the combination of ACF and arterial hypotension.
Who may be able to join
- Patients aged 18 and older with acute circulatory failure (ACF).
Who cannot join
- Low echogenicity: the inability to perform echocardiographic measurements according to established recommendations.
- Absence of the plethysmographic signal.
Trial locations and contacts
1 site in 1 country.
Morocco1 site
Avicenna Military Hospital
Marrakesh, Marrakesh Tensift El Haouz, 40000
About this study
Official title: Reliability of Plethysmographic Perfusion Index to Predict Fluid Responsiveness in Acute Circulatory Failure.
The objective of this study is to assess the reliability of the perfusion index to predict fluid responsiveness in patients with acute circulatory failure in intensive care.
Read the detailed description
In patients with acute circulatory failure, it is recommended to assess fluid responsiveness. Fluid responsiveness is defined by an increase in cardiac output of 10 to 15% after fluid loading. The assessment of fluid responsiveness usually needs cardiac output monitoring (or stroke volume). However, in limited resource settings or during the initial management of patients with acute circulatory failure, cardiac output measurement is usually unavailable. The perfusion index (PI) is derived from the plethysmographic signal of the pulse oximeter and represents the ratio between the ratio of pulsatile on non-pulsatile light absorbance of the plethysmography signal. The PI is influenced by vascular and stroke volume. The investigators hypothesized that the peripheral index could track the changes in cardiac output induced by fluid loading and therefore detect fluid responsiveness.
Adult patients with acute circulatory failure in whom physicians want to test the fluid responsiveness will be included. At baseline, the PI will be recorded. An initial echocardiography will be performed to measure the left ventricular outflow tract velocity time integral (a surrogate of stroke volume). A fluid loading with 500 ml of 0.9% Saline or Ringer Lactate will be performed. After fluid administration, the velocity time integral and the PI will be collected. Fluid-responsive patients are defined by a 15% increase in velocity time integral. The investigators will analyze the ability of the PI to detect fluid responsiveness.
- Conditions
- Fluid Responsiveness
- Being tested
- Perfusion index
- Keywords
- acute circulatory failure, fluid responsiveness, perfusion index, left ventricular outflow velocity time-integral, echocardiography
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfusion indexDiagnostic test
The perfusion index (PI) is derived from the plethysmography signal and represents the ratio of pulsatile to non-pulsatile light absorbance of the plethysmography signal.
PPG signal.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability and accuracy of the perfusion index to discriminate fluid-responsiveness.
Reliability and accuracy of the change in perfusion index to discriminate fluid-responsive patients. Fluid responsiveness is defined by an increase in the left ventricular outflow tract velocity time integral by 15% after fluid loading.
Measured: through study completion, an average of 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start10 Feb 2024
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fluid ResponsivenessStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avicenna Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younes Aissaoui, MD, Avicenna Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313671
- Sponsor's protocol ID
- Perfusion Index - FR study
- Acronym
- PPI-FR
- Status last verified
- Mar 2025
- First submitted
- 7 Jan 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study will be available from the principal investigator upon reasonable request.
Publications
Aissaoui Y, Belhadj A, Eddakya W, Bencharfa B, Bouchama A, Didi M, Elbaraka H, Fassiki N, Myatt I, Qamouss Y, Leone M, Abouqal R. Early hemodynamic phenotyping in sepsis using transthoracic echocardiography: A proof-of-concept study in a north African ICU. J Crit Care. 2026 Aug;94:155504. doi: 10.1016/j.jcrc.2026.155504. Epub 2026 Feb 26.
PubMed 41759300Aissaoui Y, Bouchama A, Abouelkemhe C, Enourhbi A, Bencharfa B, Didi M, Aguena H, Belhadj A. The reliability of the plethysmographic perfusion index for detecting fluid responsiveness in critically ill patients. J Intensive Med. 2025 Sep 27;6(1):34-41. doi: 10.1016/j.jointm.2025.07.004. eCollection 2026 Feb.
PubMed 41736778
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Plethysmographic Perfusion Index to Predict Fluid Responsiveness in Acute Circulatory Failure.
- ClinicalTrials.gov ID
- NCT06313671
- Acronym / sponsor ID
- PPI-FR / Perfusion Index - FR study
- Conditions
- Fluid Responsiveness
- Keywords
- acute circulatory failure, fluid responsiveness, perfusion index, left ventricular outflow velocity time-integral, echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Avicenna Military HospitalUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 15 Mar 2024 (actual)
- 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.
The objective of this study is to assess the reliability of the perfusion index to predict fluid responsiveness in patients with acute circulatory failure in intensive care.
Detailed description
In patients with acute circulatory failure, it is recommended to assess fluid responsiveness. Fluid responsiveness is defined by an increase in cardiac output of 10 to 15% after fluid loading. The assessment of fluid responsiveness usually needs cardiac output monitoring (or stroke volume). However, in limited resource settings or during the initial management of patients with acute circulatory failure, cardiac output measurement is usually unavailable. The perfusion index (PI) is derived from the plethysmographic signal of the pulse oximeter and represents the ratio between the ratio of pulsatile on non-pulsatile light absorbance of the plethysmography signal. The PI is influenced by vascular and stroke volume. The investigators hypothesized that the peripheral index could track the changes in cardiac output induced by fluid loading and therefore detect fluid responsiveness.
Adult patients with acute circulatory failure in whom physicians want to test the fluid responsiveness will be included. At baseline, the PI will be recorded. An initial echocardiography will be performed to measure the left ventricular outflow tract velocity time integral (a surrogate of stroke volume). A fluid loading with 500 ml of 0.9% Saline or Ringer Lactate will be performed. After fluid administration, the velocity time integral and the PI will be collected. Fluid-responsive patients are defined by a 15% increase in velocity time integral. The investigators will analyze the ability of the PI to detect fluid responsiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 and older with acute circulatory failure (ACF). ACF is defined by the presence of signs of tissue hypoperfusion: capillary refill time>5 seconds, mottling, oliguria <0.5 mL/kg/h for more than an hour), altered mental status), blood lactate >2 mmol/L or metabolic acidosis (pH <7.35 or base excess >-5). Arterial hypotension is not necessary for the diagnosis of ACF. It is defined by a systolic blood pressure (SBP) <90 mmHg, a mean arterial pressure (MAP) <65 mmHg, or a drop in SBP ≥40 mmHg. Shock is defined by the combination of ACF and arterial hypotension.
Key inclusion criteria (1 listed)
- Patients aged 18 and older with acute circulatory failure (ACF).
Key exclusion criteria (2 listed)
- Low echogenicity: the inability to perform echocardiographic measurements according to established recommendations.
- Absence of the plethysmographic signal.
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 |
|---|---|---|
| Perfusion indexThe perfusion index (PI) is derived from the plethysmography signal and represents the ratio of pulsatile to non-pulsatile light absorbance of the plethysmography signal. PPG signal. | Diagnostic test | – |
Primary outcome
Reliability and accuracy of the perfusion index to discriminate fluid-responsiveness.
Time frame: through study completion, an average of 9 months.
Reliability and accuracy of the change in perfusion index to discriminate fluid-responsive patients. Fluid responsiveness is defined by an increase in the left ventricular outflow tract velocity time integral by 15% after fluid loading.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Derived from this study: PubMed 41759300Aissaoui Y, Belhadj A, Eddakya W, Bencharfa B, Bouchama A, Didi M, Elbaraka H, Fassiki N, Myatt I, Qamouss Y, Leone M, Abouqal R. Early hemodynamic phenotyping in sepsis using transthoracic echocardiography: A proof-of-concept study in a north African ICU. J Crit Care. 2026 Aug;94:155504. doi: 10.1016/j.jcrc.2026.155504. Epub 2026 Feb 26.
- Derived from this study: PubMed 41736778Aissaoui Y, Bouchama A, Abouelkemhe C, Enourhbi A, Bencharfa B, Didi M, Aguena H, Belhadj A. The reliability of the plethysmographic perfusion index for detecting fluid responsiveness in critically ill patients. J Intensive Med. 2025 Sep 27;6(1):34-41. doi: 10.1016/j.jointm.2025.07.004. eCollection 2026 Feb.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study will be available from the principal investigator upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Responsiveness, run by Avicenna Military Hospital at 1 site in Morocco.
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 2 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: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Morocco. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability and accuracy of the perfusion index to discriminate fluid-responsiveness. (time frame: through study completion, an average of 9 months.). 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 NCT06313671, which also lists 2 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 11 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.