Pressure-dependent Changes in Hematocrit and Plasma Volume During Anesthesia

April 4, 2015 updated by: Tor Damén, Sahlgrenska University Hospital, Sweden
The arterial blood pressure affects the ratio between filtration and reabsorption of fluids in the circulating blood volume and thereby the hematocrit. During induction of anesthesia blood pressure, hemoglobin level and hematocrit decreases. The aim of the study is to evaluate weather a maintained blood pressure with norepinephrine during anesthesia induction reduces the decrease in hematocrit.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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. Arterial blood gas will be analysed every ten minutes. Equal anesthesia in both groups will be monitored. No fluids will be infused. Noninvasive continuous hemoglobin measurement (SpHb) will be measured.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 41345
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective coronary artery surgery patients

Exclusion Criteria:

  • Age under 18 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Maintained blood pressure
Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion
Procedure: Maintained blood pressure
Norepinephrine therapy to maintain preanesthesia blood pressure
Drug: Norepinephrine
Norepinephrine therapy to maintain preanesthesia blood pressure
Other Names:
  • Vasopressor
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The magnitude and dynamics of the decrease in hematocrit during anesthesia induction
Time Frame: 70 minutes from anesthesia induction
70 minutes from anesthesia induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduced hematocrit decrease by vasopressor infusion maintained blood pressure
Time Frame: 70 minutes from anesthesia induction
To assess if the decrease in hematocrit can be reduced, by maintaining the blood pressure with vasopressor infusion
70 minutes from anesthesia induction

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of continuous non-invasive hemoglobin monitoring (SpHb) to invasive Hb levels
Time Frame: 70 minutes from anesthesia induction
To evaluate if changes in invasive measured Hb levels, can be measured by continuous non-invasive hemoglobin monitoring (SpHb).
70 minutes from anesthesia induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Andreas Nygren, MD PHD, Sweden: Sahlgrenska University hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

April 4, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 4, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDamen

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blood Pressure

Clinical Trials on Maintained blood pressure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe