The Relationship Between Cardiac Output and Microvascular Visceral Blood Flow

NCT02167178 | Completed

• 1 other identifier: A12012012
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Although major surgery is often required to treat abdominal problems, there is a significant risk of death or complication following these operations. By using ultrasound the amount and timing of fluid patients receive during operations can be optimised and the risk of surgery reduced. However, little is known about the exact changes in blood flow in the small vessels of the body in response to fluid. A greater understanding of this may allow for more appropriate care of patients undergoing this type of surgery in the future. In this study of healthy volunteers we will attempt to better understand how fluid administration guided by ultrasound effects blood flow in large and small vessels, by using two different techniques of ultrasound imaging. A narrow bore (approximately 4-5mm diameter) ultrasound probe will be passed through the nostril and mouth to rest within the oesophagus allowing measurement of blood flow in the main artery, while a second probe will be rested on the volunteer's abdomen and used to record changes in blood flow in small liver blood vessels. Comparison of these two techniques during the administration of fluid will allow us to better understand the relationship between large and small vessel blood flow. Because different types of fluid may behave in different ways, we will test the effect of two types of fluid commonly used in clinical practice; 'normal' saline solution and gelofusine.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Change in microvascular visceral blood flow

  Microvascular visceral blood flow is assessed using contrast enhanced ultrasound scanning, following stroke volume optimisation.

  30 minutes

Secondary Outcomes (2)

• Change in stroke volume

  30 minutes

• Change in haematocrit

  60 minutes

Study Arms (2)

Volunteers receiving 0.9% NaCl

Volunteers receiving 0.9% NaCl to optimise stroke volume

Other: Administration of 0.9% NaCl solution; Other: Measurement of stroke volume; Other: Measurement of microvascular blood flow

Volunteers receiving gelofusine

Volunteers receiving gelofusine to optimise stroke volume

Other: Measurement of stroke volume; Other: Measurement of microvascular blood flow; Other: Administration of gelofusine

Interventions

Administration of 0.9% NaCl solution OTHER

Volunteers administered 0.9% NaCl solution in 250ml boluses

Also known as: Normal saline, Saline

Volunteers receiving 0.9% NaCl

Measurement of stroke volume OTHER

The measurement of stroke volume will be performed using an Oesophageal Doppler Monitor.

Volunteers receiving 0.9% NaCl; Volunteers receiving gelofusine

Measurement of microvascular blood flow OTHER

Microvascular blood flow will be measured using a contrast enhanced ultrasound scan.

Also known as: CEUS, Contrast enhanced ultrasound scan, SonoVue.

Volunteers receiving 0.9% NaCl; Volunteers receiving gelofusine

Administration of gelofusine OTHER

Volunteers administered gelofusine in 250ml boluses

Volunteers receiving gelofusine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy male volunteers, aged 18-80.

You may qualify if:

• male
• age 18-80 years
• body mass index 20-30kg/m2

You may not qualify if:

• BMI \< 20 or \> 30 kg/m2.
• Active cardiovascular disease: uncontrolled hypertension (BP \> 160/100), angina, heart failure (class III/IV), arhythmias , right to left cardiac shunt or recent cardiac event.
• Individuals taking beta-adrenergic blocking agents.
• Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial)..
• Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, types 1 or 2 diabetes.
• Active inflammatory bowel disease, or renal disease,
• Malignancy
• Clotting dysfunction
• Previous oesophageal surgery
• Individuals with a known history of oesophageal varices
• Individuals with a known history of epistaxis
• Family history of early (\<55y) death from cardiovascular disease.
• Known sensitivity to SonoVue
• Known sensitivity to gelofusine

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham, School of Medicine, Division of Medical Sciences and Graduate Entry Medicine

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

MeSH Terms

Interventions

Saline Solution; Sodium Chloride; contrast agent BR1

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• John P Williams, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 18, 2014
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

GB (1)