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

NCT02832596 | Completed

• 1 other identifier: Plasmavolume TDamen
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Pressure; Anesthesia

Keywords

Anesthesia; Blood pressure; Plasma Volume; Vasopressor agents; Coronary artery bypass; Glycocalyx; ANP; Coagulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Difference in 125I-HSA leakage

  50 minutes from anesthesia induction

• ANP, heparan sulphate, thrombomodulin, fibrinogen, ROTEM

  50 minutes from anesthesia induction

Study Arms (2)

Control

NO INTERVENTION

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.

Maintained blood pressure

ACTIVE COMPARATOR

Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion

Drug: Norepinephrine; Procedure: Maintained blood pressure

Interventions

Norepinephrine DRUG

Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion

Also known as: Vasopressor

Maintained blood pressure

Maintained blood pressure PROCEDURE

Norepinephrine therapy to maintain preanesthesia blood pressure

Maintained blood pressure

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective coronary artery surgery patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Norepinephrine; Vasoconstrictor Agents

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Andreas Nygren, MD PHD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 14, 2016
• Study Start: October 1, 2016
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

SE (1)