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

NCT ID: NCT02832596

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-08-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Blood Pressure Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Maintained blood pressure

Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion

Group Type ACTIVE_COMPARATOR

Norepinephrine

Intervention Type DRUG

Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion

Maintained blood pressure

Intervention Type PROCEDURE

Norepinephrine therapy to maintain preanesthesia blood pressure

Interventions

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Norepinephrine

Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion

Intervention Type DRUG

Maintained blood pressure

Norepinephrine therapy to maintain preanesthesia blood pressure

Intervention Type PROCEDURE

Other Intervention Names

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Vasopressor

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tor Damén

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Nygren, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Plasmavolume TDamen

Identifier Type: -

Identifier Source: org_study_id

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