Pressure-dependent Changes in Hematocrit and Plasma Volume During Anesthesia

Anesthesia Clinical Trial

Official title:

Pressure-dependent Changes in Hematocrit and Plasma Volume During Anesthesia

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02412189
• Other study ID #: TDamen
• Status: Unknown status
• Phase: N/A
• First received: March 10, 2015
• Last updated: April 4, 2015
• Start date: February 2014
• Est. completion date: May 2015

Study information

• Verified date: April 2015
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Tor Damén, MD
• Phone: +46313427873
• Email: tor.damen[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 24
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Blood Pressure
• Hematocrit Change

Intervention

Procedure:
• Maintained blood pressure
Norepinephrine therapy to maintain preanesthesia blood pressure

Drug:
• Norepinephrine
Norepinephrine therapy to maintain preanesthesia blood pressure

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accuracy of continuous non-invasive hemoglobin monitoring (SpHb) to invasive Hb levels	To evaluate if changes in invasive measured Hb levels, can be measured by continuous non-invasive hemoglobin monitoring (SpHb).	70 minutes from anesthesia induction
Primary	The magnitude and dynamics of the decrease in hematocrit during anesthesia induction		70 minutes from anesthesia induction
Secondary	Reduced hematocrit decrease by vasopressor infusion maintained blood pressure	To assess if the decrease in hematocrit can be reduced, by maintaining the blood pressure with vasopressor infusion	70 minutes from anesthesia induction