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NCT Number: NCT02832596

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

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.

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Key information

Conditions

Blood Pressure Anesthesia Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

norepinephrine

Drug

Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion

Other names: Vasopressor

Maintained blood pressure

Procedure

Norepinephrine therapy to maintain preanesthesia blood pressure

Primary outcomes

  1. The change of plasma volume measured by 125I-HSA before anesthesia induction until 50 minutes after anesthesia induction.

    Time frame: 50 minutes from 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.

Secondary outcomes

  1. Difference in 125I-HSA leakage

    Time frame: 50 minutes from anesthesia induction

    To assess if there is a difference in 125I-HSA leakage in between the control and intervention groups before and after anaesthesia induction

  2. ANP, heparan sulphate, thrombomodulin, fibrinogen, ROTEM

    Time frame: 50 minutes from anesthesia induction

    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

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 14, 2016
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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