Evaluating perfusion index changes induced by a tidal volume challenge as a predictor of fluid responsiveness in mechanically ventilated patients with sepsis and septic shock

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202605788405087

Enrollment

Registered

2026-05-14

Start date

2025-07-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia

Interventions

Fluid responder

Non fluid respdoner

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients (age 18-65 years) diagnosed with sepsis or septic shock, according to the diagnostic criteria of sepsis III definition of the European Society of Intensive Care Medicine (ESICM). • Invasive mechanical ventilation in assist-controlled mode. • Patients in sinus rhythm. • Males and Females are included.

Exclusion criteria

Exclusion criteria: Spontaneous breathing patients. • atrial fibrillation or frequent extrasystoles, because these conditions are responsible for an unstable PI signal. • severe valvular heart disease. • Poor lung compliance (Cs <30 ml/cmH2O). • Open chest or chest drainage was in place. • Difficulty in getting an adequate echocardiography window (morbid obesity (BMI=40 Kg/M) and chest wall trauma. • Pulmonary hypertension. • Pregnancy. • Patients admitted with severe burn

Design outcomes

Primary

Measure	Time frame
Assess the ability of PI changes induced by a VT challenge to diagnose preload responsiveness in critically ill adult patients.	—

Secondary

Measure	Time frame
Correlation between changes in CI after a VT challenge and after a volume expansion challenge test. • Assess the ability of SVV by electrical cardiometry to diagnose preload responsiveness in critically ill adult patients. • ICU length of stay between the fluid responsiveness group and the fluid non- responsiveness group. • 7-day mortality between the fluid responsiveness group and the fluid non- responsiveness group	—

Measure

Time frame

Correlation between changes in CI after a VT challenge and after a volume expansion challenge test. • Assess the ability of SVV by electrical cardiometry to diagnose preload responsiveness in critically ill adult patients. • ICU length of stay between the fluid responsiveness group and the fluid non- responsiveness group. • 7-day mortality between the fluid responsiveness group and the fluid non- responsiveness group

—

Countries

Egypt

Contacts

Public ContactNaglaa Samy

Lecteurer

naglasamy.ns@gmail.com+201066361920

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026