Effect of Albumin Replacement on Oxygen Delivery in Sepsis Patients

NCT06556914 | Recruiting

• 1 other identifier: albumin do2
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Intensive Care Unit

Keywords

oxygen delivery; Sepsis; albumin deficiency

Outcome Measures

Primary Outcomes (1)

• oxygen delivery

  Effect of albumin replacement on oxygen delivery.Arterial oxygen saturation (SaO2), hemoglobin (Hb), partial pressure of oxygen in the arterial blood (PaO2) values will be obtained by blood gas measurements.DO2(oxygen delivery): CO x 10 x (Hbx1,34x SaO2) When oxygen delivery to tissue is calculated according to this formula, normal values are 5 x 10 x 15 x 1,34 x 0.98 =984 ml/dk.

  Up to 1 hour after albumin replacement

Secondary Outcomes (1)

• change in SOFA score

  Up to 12 hour after albumin replacement

Study Arms (1)

group albumin

The 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Arterial oxygen saturation (SaO2), hemoglobin (Hb), partial pressure of oxygen in the arterial blood (PaO2) values will be obtained by blood gas measurements. Cardiac output will be calculated from the parasternal long axis window by transthoracic echocardiography and left ventricular outflow tract (LVOT) measurement. LVOT peak velocity measurement (VTI) will be displayed in PulseWave mode through the apical 5-window window. During measurement, the image will be frozen and VTI will be measured from the widest wave. The 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.

You may qualify if:

• Followed up with a diagnosis of sepsis,
• over 18 years old
• Patients who were diagnosed with hypo-albuminemia after more than 4L/day fluid resuscitation and underwent albumin replacement

You may not qualify if:

• Consent is not given by the patient or his/her guardian,
• The initial cause of shock was hypovolemic, cardiogenic or obstructive shock.
• Pregnancy or suspected pregnancy
• Peripheral limb or severe organ ischemia with peripheral artery disease
• Cardiac functions cannot be evaluated optimally by transthoracic echocardiography
• Patients who died within the first 24 hours after intensive care admission

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University

Samsun, Ilkadım, 55100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Shasthry SM, Kumar M, Khumuckham JS, Sarin SK. Changes in cardiac output and incidence of volume overload in cirrhotics receiving 20% albumin infusion. Liver Int. 2017 Aug;37(8):1167-1176. doi: 10.1111/liv.13375. Epub 2017 Mar 5.

  PMID: 28135785 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• gamze MD ertaş, specialist

  Samsun University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gamze MD ertaş, specialist

CONTACT

5056587914; gamzeertas555@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 16, 2024
• Study Start: November 15, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 15, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

TU (1)