Viewing Study NCT06556914



Ignite Creation Date: 2024-10-26 @ 3:38 PM
Last Modification Date: 2024-10-26 @ 3:38 PM
Study NCT ID: NCT06556914
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-13

Brief Title: Effect of Albumin Replacement on Oxygen Delivery in Sepsis Patients
Sponsor: None
Organization: None

Study Overview

Official Title: Effect of Albumin Replacement on Oxygen Delivery in Sepsis Patients
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Fluid resuscitation is a critical component of sepsis treatment Research has shown that intravenous IV fluid therapy in sepsis positively impacts cardiac output and thereby oxygen O2 delivery through a complex interaction of central venous pressure right atrial pressure venous resistance ventricular compliance cardiac contractility and systemic vascular resistance The 2021 sepsis prevention guidelines recommend balanced crystalloids as first-line therapy However no studies in the literature have evaluated the effect of albumin on O2 delivery In our study the investigators aim to assess the impact of albumin replacement on O2 delivery in sepsis patients in the intensive care unit
Detailed Description: Patients will be admitted from the emergency room operating room or medical wards After obtaining written consent from the patients or their guardians patients who are followed up in the intensive care unit with a diagnosis of sepsis patients over the age of 18 who are diagnosed with hypo-albuminemia after more than 4 Lday fluid resuscitation and who undergo albumin replacement will be included in the study Treatment support for sepsis patients will be organized according to international guidelines and our local protocol with appropriate antibiotic therapy fluid infusion Crystalloids 20 mLKg norepinephrine infusion to keep mean arterial pressure MAP65 mmHg and infection source control Demographic information of the patients sepsis cause systemic diseases surgical history Sequential Organ Failure Assessment SOFA score which shows the severity of the disease Acute Physiology and Chronic Health Evaluation APACHE II score hemodynamic variables blood gas parameters complete blood count and blood biochemistry values total daily fluid intake and excretion and daily fluid balance will be recorded

For patients with a plasma albumin value below 25 ddL who require 4 L or more of crystalloid per day 20 Albumin 100 mL will be administered as an intravenous infusion over a minimum of 15 minutes once a day for 3 daysThe effect of albumin replacement on the measurements will be evaluated by calculating the ECHO findings blood gas parameters and SOFA score of the study patients before and after albumin replacement Oxygen delivery will be calculated 6 times in total for 3 days and the SOFA score will be calculated 3 times in total once a day

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None