Ignite Creation Date:
2024-07-17 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499701
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-07
Brief Title:
Volume Kinetics of Fluid Resuscitation in Early Sepsis
Sponsor:
Institutul de Urgenţă pentru Boli Cardiovasculare ProfDr CC Iliescu
Organization:
Institutul de Urgenţă pentru Boli Cardiovasculare ProfDr CC Iliescu
Study Overview
Official Title:
Volume Kinetics of Fluid Resuscitation With 30 mlkg Ringer Lactate in Early Sepsis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The recommended volume resuscitation for patients with early sepsis-induced hypoperfusion is at least 30 mlkg of crystalloid administered within the first three hours However this standardized approach does not account for individual patient variability and lacks personalization Additionally the effects of administering 30 mlkg on intercompartmental fluid shifts between the plasma and interstitial compartments remain unclear This study aims to describe the volume kinetics of administering 30 mlkg of Ringers Lactate in patients with early sepsis-induced hypoperfusion within the first three hours
Detailed Description:
Adult patients admitted to the intensive care unit ICU with sepsis as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to receiving adequate volume resuscitation ie 30 mlkg of crystalloid are administered Ringers Lactate at a dose of 30 mlkg The initial 20 mlkg is infused at a constant rate over the first 30 minutes followed by a 30-minute pause with an additional 10 mlkg administered over the subsequent 15 minutes completing the infusion within 75 minutes
Up to 180 minutes post-infusion no other fluids eg gelatin albumin are administered except for antibiotics sedatives or vasoactive substances as needed Ideally only one catecholamine eg norepinephrine is administered The volume and quantity of these substances are recorded Arterial blood samples are collected for blood gas analysis including hemoglobin levels Urinary output is measured at 30 60 and 180 minutes and any blood loss other than the 15 ml per sample collected is quantified during hemoglobin monitoring Additionally urinary creatinine concentration is determined from urine samples collected at baseline
The hemodilution data are utilized as input into a three-compartment model with microconstants for fluid redistribution and excretion
Up to 180 minutes post-infusion no other fluids eg gelatin albumin are administered except for antibiotics sedatives or vasoactive substances as needed Ideally only one catecholamine eg norepinephrine is administered The volume and quantity of these substances are recorded Arterial blood samples are collected for blood gas analysis including hemoglobin levels Urinary output is measured at 30 60 and 180 minutes and any blood loss other than the 15 ml per sample collected is quantified during hemoglobin monitoring Additionally urinary creatinine concentration is determined from urine samples collected at baseline
The hemodilution data are utilized as input into a three-compartment model with microconstants for fluid redistribution and excretion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None