Changes in Measured Plasma Volume, Glycocalyx and Atrial Natriuretic Peptide During Anaesthesia

Anesthesia Clinical Trial

Official title:

Changes in Measured Plasma Volume, Glycocalyx and Atrial Natriuretic Peptide During Anaesthesia, a Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832596
• Other study ID #: Plasmavolume TDamen
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 20, 2019

Study information

• Verified date: April 2020
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The arterial blood pressure is thought to affect the ratio between filtration and reabsorption of fluids in the circulating blood volume and thereby the plasma volume. During induction of anesthesia blood pressure, hemoglobin level and hematocrits decreases and the plasma volume increases. The aim of the study is to evaluate weather a maintained blood pressure with norepinephrine during anesthesia induction reduces the increase in 125 iodine-labeled human serum albumine (125I-HSA) measured plasma volume.

Description:

24 patients scheduled for coronary artery bypass surgery will be included and randomized to receive either norepinephrine in the dose needed to maintain pre-anesthesia blood pressure or to a control group and receive norepinephrine only if mean arterial pressure decreases below 60 mmHg. Equal anesthesia in both groups will be monitored. No fluids will be infused.

Changes in vascular resistance and cardiac output will be measured with thermodilution and changes in plasma volume will be measured with 125I-HSA.

Endothelial cell function will be evaluated by measuring leakage of 125I-HSA and the plasma concentration of endothelial cell markers. Hormonal effects will be evaluated by measuring the plasma concentration of atrial natriuretic peptide (ANP). Shedding of glycocalyx will be evaluated by measuring heparan sulphate. The level of fibrinogen and platelet function will be evaluated by thromboelastography/multiplate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 20, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• Elective coronary artery surgery patients

Exclusion Criteria:

• Age under 40 years

• Untreated hypertension

• A reduced left ventricular systolic ejection fraction of 45% or less

• Diabetes mellitus

• Former stroke and/or a known carotid artery stenosis

Related Conditions & MeSH terms

• Anesthesia
• Blood Pressure

Intervention

Drug:
• Norepinephrine
Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion

Procedure:
• Maintained blood pressure
Norepinephrine therapy to maintain preanesthesia blood pressure

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of plasma volume measured by 125I-HSA before anesthesia induction until 50 minutes after anesthesia induction.	To assess if the increase in plasma volume measured by 125I-HSA can be reduced by maintaining the blood pressure with vasopressor infusion.	50 minutes from anesthesia induction
Secondary	Difference in 125I-HSA leakage	To assess if there is a difference in 125I-HSA leakage in between the control and intervention groups before and after anaesthesia induction	50 minutes from anesthesia induction
Secondary	ANP, heparan sulphate, thrombomodulin, fibrinogen, ROTEM	To assess if there is a difference in the plasma concentration of ANP, heparan sulphate, thrombomodulin, fibrinogen and ROTEM before and after anaesthesia induction in the intervention group compared to the control group	50 minutes from anesthesia induction