NCT06122909

Brief Summary

The aim of this study is to compare the effect of resuscitation guided by Left ventricular outflow tract-velocity time integral (LVOT-VTI) variation versus the effect of resuscitation guided by inferior vena cava (IVC) variation on time to normalization of the capillary refill time in adult patients with septic shock, amount of resuscitation fluids, rate of vasopressor and ICU length of stay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

November 3, 2023

Last Update Submit

April 26, 2025

Conditions

Septic ShockResuscitation

Keywords

capillary refill timeseptic shockresuscitationultrasounddynamic

Outcome Measures

Primary Outcomes (1)

  • Time to normalization of the capillary refill time (≤ 3 sec)

    Time to normalization of the capillary refill time (≤ 3 sec.) in adult patients with septic shock at 6h of septic shock recognition in patients with delayed capillary refill time (\> 3 sec.)

    12 hours

Secondary Outcomes (4)

  • Amount of resuscitation fluids

    24 hours

  • Total amount of vasopressors.

    24 hours

  • Change in Creatinine-based Kidney Disease: Improving Global Outcome (KDIGO) score

    72 hours

  • ICU length of stay

    1 week

Study Arms (2)

Group VTI

EXPERIMENTAL

Group VTI (n=45): will receive resuscitation guided by LVOT-VTI variation after PLR test.

Drug: Group VTI

Group IVC

ACTIVE COMPARATOR

Group IVC (n=45): will receive resuscitation guided by IVC diameter variation after PLR test.

Drug: Group IVC

Interventions

Group VTIDRUG

Group VTI will receive resuscitation guided by LVOT-VTI variation after PLR test.

Group VTI
Group IVCDRUG

Group IVC will receive resuscitation guided by IVC diameter variation after PLR test.

Group IVC

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adult patients ( ≥ 18 years) of either gender with septic shock according to the Sepsis-3

You may not qualify if:

  • Known history of any cardiac pathology, acute coronary syndrome, cardiac dysrhythmias (as a primary diagnosis), acute pulmonary edema or known poor systolic cardiac function (left ventricular ejection fraction \< 50%).
  • Body mass index ≥ 35 kg/m2 .
  • Concomitant acute respiratory distress syndrome) or high PEEP (\> 10 cmH2O) requirements on mechanical ventilation (MV).
  • Child B or C liver cirrhosis.
  • End-stage renal disease with or without dialysis.
  • Pregnancy.
  • Multi-organ system failure.
  • Active hemorrhage.
  • Head trauma.
  • Intra-abdominal hypertension (\> 15 mmHg).
  • Declined to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mansoura University, Central Hospital

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Cairo university hospitals, kasralainy

Cairo, 11559, Egypt

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Both participants and outcome assessors will be blinded to the groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Left ventricular outflow tract-velocity time integral (LVOT-VTI) resuscitation based group Inferior vena cava (IVC) diameter variation resuscitation based group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator, Asst. professor of anesthesia, Cairo university

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 8, 2023

Study Start

July 21, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)