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

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Anesthesia
• Intervention / Treatment: Drug: Norepinephrine; Procedure: Maintained blood pressure

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Ordinary anesthesia, mean arterial pressure allowed to decrease to 60 mmHg. If it is lower the patients will receive a norepinephrine infusion in order to raise the mean arterial pressure to 60 mmHg.
Active Comparator: Maintained blood pressure; Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion	Drug: Norepinephrine; Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion; Other Names: Vasopressor; Procedure: Maintained blood pressure; Norepinephrine therapy to maintain preanesthesia blood pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Andreas Nygren, MD PHD, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): August 20, 2019

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Blood pressure; Anesthesia; Coronary artery bypass; Coagulation; Glycocalyx; Vasopressor agents; Plasma Volume; ANP
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine
• Other Study ID Numbers: Plasmavolume TDamen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided