Pressure-dependent Changes in Hematocrit and Plasma Volume During Anesthesia

NCT02412189 | Unknown

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

Brief Summary

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.

Conditions

Blood Pressure; Hematocrit Change; Anesthesia

Keywords

Anesthesia; Blood pressure; Plasma volume; Vasopressor agents; Continuous noninvasive hemoglobin measurement; Coronary artery bypass

Outcome Measures

Primary Outcomes (1)

• The magnitude and dynamics of the decrease in hematocrit during anesthesia induction

  70 minutes from anesthesia induction

Secondary Outcomes (1)

• Reduced hematocrit decrease by vasopressor infusion maintained blood pressure

  70 minutes from anesthesia induction

Other Outcomes (1)

• Accuracy of continuous non-invasive hemoglobin monitoring (SpHb) to invasive Hb levels

  70 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

Procedure: Maintained blood pressure; Drug: Norepinephrine

Interventions

Maintained blood pressure PROCEDURE

Norepinephrine therapy to maintain preanesthesia blood pressure

Maintained blood pressure

Norepinephrine DRUG

Norepinephrine therapy to maintain preanesthesia blood pressure

Also known as: Vasopressor

Maintained blood pressure

Eligibility Criteria

• Age: 18 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 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.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden, 41345, Sweden

RECRUITING

MeSH Terms

Interventions

Norepinephrine; Vasoconstrictor Agents

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

  Sweden: Sahlgrenska University hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tor Damén, MD

CONTACT

+46313427873; tor.damen@vgregion.se

Andreas Nygren, MD

CONTACT

+46313427444; andreas.nygren@aniv.gu.se

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: MD

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: April 9, 2015
• Study Start: February 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

SE (1)