- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03805321
The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness
The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness Using Mini-fluid Challenge Test
Studieoversikt
Status
Forhold
Detaljert beskrivelse
The concept of fluid responsiveness has been suggested to guide fluid administration in critically ill patients to avoid either over or under-transfusion.
Several methods have been suggested to detect fluid responsiveness. Mini fluid challenge with concomitant monitoring of stroke volume is one of the most robust methods for pre-load challenge.
The main foreshortening of mini fluid challenge method is the need for a real-time cardiac output monitor, to track the instantaneous change of stroke vole with changing body position. Finding a surrogate to cardiac output to trace the effect of mini fluid challenge would make the test more applicable without the need for advanced hemodynamic monitors.
There is a growing interest in the use of perfusion indices in assessment of fluid responsiveness. Perfusion indices are measures for adequacy of oxygen delivery in peripheral tissues; thus, they were hypothesized to be possible surrogates of cardiac output. Peripheral perfusion index represents "the ratio between the pulsatile and non-pulsatile component of the light reaching the pulse oximeter" . Peripheral perfusion index has been considered as a numerical non-invasive measure for peripheral perfusion. PPI has the advantage over other perfusion indices that it a non-invasive, user-friendly monitor.
The aim of this work is to investigate the ability of peripheral perfusion index to predict the hemodynamic response to mini-fluid challenge in patients with septic shock.
Mini-fluid challenge test will be performed by infusion of 200 mL Lactated Ringer's solution over 1 minute. Velocity time integral will be monitored using Transthoracic echocardiography at the left ventricular outflow tract at the apical five-chamber view. Cardiac output will be calculated, and the patient will be considered fluid-responder if cardiac output increased by 10% after fluid challenge.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Cairo, Egypt, 11432
- Ahmed Mohamed Hasanin
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Septic shock patients
Exclusion Criteria:
- Evident blood loss
- Peripheral vascular disorders
- Upper limb injury or burns
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Peripheral perfusion index
Tidsramme: 2 hours
|
It is a number describing the ratio between pulsatile and non-pulsatile blood flow measured by pulse oximeter.
It is measured in percent.
with the best value of 20% and the worst value of 0.1%
|
2 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Velocity time integral
Tidsramme: 2 hours
|
it is a parameter measured from Doppler across the left ventricular outflow tract.
It is calculated by dividing the blood velocity by time and measured in cm
|
2 hours
|
|
Mean arterial blood pressure
Tidsramme: 2 hours
|
Mean arterial blood pressure measured in mmHg
|
2 hours
|
|
Central venous pressure
Tidsramme: 2 hours
|
Central venous pressure measured from a central venous catheter.
It is measured in cmH2o
|
2 hours
|
|
Systolic arterial blood pressure
Tidsramme: 2 hours
|
Systolic arterial blood pressure measured in mmHg
|
2 hours
|
|
Diastolic arterial blood pressure
Tidsramme: 2 hours
|
Diastolic arterial blood pressure measured in mmHg
|
2 hours
|
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Cardiac output
Tidsramme: 2 hours
|
The amount of blood pumped by the heart in one minute.
it is measured as liters per minute
|
2 hours
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Ahmed Shash, Professor, Head of department of anesthesia, Cairo University, Egypt
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- N-138-2018
Plan for individuelle deltakerdata (IPD)
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