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A study to compare ultrasound guided volume status parameters with blood pressure variables in predicting whether a patient with fall in blood pressure will respond to giving fluid or not.

Comparison of Pulse Pressure Variation, Inferior Vena Cava Distensibility Index, Hemodynamics and Changes in Hemodynamics in Response to Mini Fluid Challenge as Predictor of Fluid Responsiveness. - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089816
Enrollment
50
Registered
2025-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: R579- Shock, unspecified

Interventions

Intervention1: Fluid Responsiveness by Fluid Challenge: A Fluid challenge of 4ml/kg of predicted body weight will be infused over 1-2 Mins. Fluid bolus will be stopped in case of rapidly rising oxygen

Sponsors

Dr Ruchi Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. More than or equal to 18 years of age on mechanical ventilation admitted in ICU 2. Clinical signs of shock, defined as any of the following: a.MAP less than 65mmHg b.Requiring vasopressors support to maintain MAP more than 65mmHg c.Lactate more than 2mmol per L d.Oliguria less than 0.5ml per kg per hour urine output e.Capillary refill time more than 5sec.

Exclusion criteria

Exclusion criteria: 1.Cardiac arrythmias 2.Moderate to severe valvular dysfunction 3.Poor echo window 4.Increased intraabdominal pressure 5.Large intra-abdominal masses or ascites causing IVC compression. 6.Right heart failure, acute Cor pulmonale 7.Patient not giving consent to get included in study. 8.Spontaneous breathing efforts (interferes with heart-lung interaction). 9.Severe obstructive airway diseases (e.g., COPD exacerbation, asthma with active bronchospasm).

Design outcomes

Primary

MeasureTime frame
To evaluate the predictive power of Pulse Pressure Variation (PPV) and the Distensibility Index of the Inferior Vena Cava (DIVC) in predicting fluid responsiveness in mechanically ventilated patients with undifferentiated shock.Timepoint: Before and after completion of fluid bolus.

Secondary

MeasureTime frame
To compare the predictive power of PPV and DIVC as dynamic parameters for prediction of fluid responsiveness among responders and non-responders.Timepoint: Pre fluid challenge;To analyze the changes in hemodynamic parameters after a fluid challenge and their association with fluid responsivenessTimepoint: pre and post fluid challenge;To assess the predictive performance of PPV and DIVC across subgroups, such as: 1.Septic vs. non-septic shock patients. 2.Patients with varying vasopressor (norepinephrine equivalent) requirements. Timepoint: prefluid challenge;To determine the impact of baseline clinical and hemodynamic variables, such as central venous pressure (CVP) and baseline vasopressor support, on fluid responsiveness.Timepoint: prefluid challenge;To validate the reliability of PPV and DIVC under varying clinical conditions, such as different driving pressures and PEEP levels, through subgroup analyses.Timepoint: prefluid challenge

Countries

India

Contacts

Public ContactDr Sumit Ray

Holy Family Hospital

ruchi_gupta.mamc@yahoo.co.in9910695602

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026