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

This study is currently recruiting participants.
Verified November 2017 by Tor Damén, Sahlgrenska University Hospital, Sweden
Sponsor:
ClinicalTrials.gov Identifier:
NCT02832596
First Posted: July 14, 2016
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tor Damén, Sahlgrenska University Hospital, Sweden
  Purpose
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.

Condition Intervention
Blood Pressure Anesthesia Drug: Norepinephrine Procedure: Maintained blood pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Changes in Measured Plasma Volume, Glycocalyx and Atrial Natriuretic Peptide During Anaesthesia, a Randomised Clinical Trial

Resource links provided by NLM:


Further study details as provided by Tor Damén, Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • 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


Estimated Enrollment: 24
Study Start Date: October 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Vasopressor
Procedure: Maintained blood pressure
Norepinephrine therapy to maintain preanesthesia 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.

  Eligibility

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832596


Contacts
Contact: Tor Damén, MD +46313427873 tor.damen@vgregion.se

Locations
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 41345
Contact: Andreas Nygren, MD PHD    +46313427444    andreas.nygren@aniv.gu.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Andreas Nygren, MD PHD Sahlgrenska University Hospital, Sweden
  More Information

Responsible Party: Tor Damén, Doctor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02832596     History of Changes
Other Study ID Numbers: Plasmavolume TDamen
First Submitted: July 11, 2016
First Posted: July 14, 2016
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Tor Damén, Sahlgrenska University Hospital, Sweden:
Anesthesia
Blood pressure
Plasma Volume
Vasopressor agents
Coronary artery bypass
Glycocalyx
ANP
Coagulation

Additional relevant MeSH terms:
Anesthetics
Norepinephrine
Vasoconstrictor Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents