Healthy Volunteers Clinical Trial
Official title:
Investigation of the Relationship Between Oesophageal Doppler Assessed Increases in Cardiac Output and Microvascular Visceral Blood Flow in Healthy Volunteers
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.
Optimizing intravascular volume and cardiac output are essential to ensure adequate organ
perfusion in patients who are undergoing major surgery. To enable this cardiac output is
frequently monitored during operation using a variety of techniques; one such technique is
trans-oesophageal Doppler ultrasound also known as oesophageal Doppler monitoring (ODM). ODM
measurement of cardiac output is a less invasive technique than many currently used methods,
and has recently been recommended by NICE for adoption in clinical practice.
The matching of microvascular blood flow, cardiac output and fluid administration is
advantageous for visceral organs, in marrying demands for oxygen and nutrients to their
delivery. However, although there is evidence to suggest that intraoperative ODM directed
fluid administration can improve outcomes in the perioperative period, reducing hospital
stay and complications, there is little direct evidence that optimization of cardiac output
via ODM improves the microvascular blood flow to the visceral organs which are frequently
compromised by major surgical interventions. A greater appreciation of the effect of ODM
guided fluid replacement on the delivery of blood and hence oxygen and nutrients to these
vital organs could help with the development of more refined algorithms for fluid
administration in a clinical setting in the future. In our clinical physiology laboratories
we regularly employ contrast-enhanced ultrasound (CEUS) using a Phillips iU22, to visualize
microvascular blood flow in healthy young and elderly men following a variety of
physiological challenges. This minimally invasive ultrasound based imaging technique is
ideal for gaining an insight into the effect various physiological interventions have on
tissue blood flow and could be readily used to chart changes in visceral microvascular flow
following ODM guided fluid optimization. Transference of this investigative approach to a
clinical setting has the potential to greatly improve the care of the surgical patient
requiring fluid resuscitation.
Different types of intravenous fluids are used in clinical practice. These are primarily
crystalloid solutions, such as 0.9% sodium chloride (`normal` saline), or colloidal
suspensions, such as gelofusine. There is good experimental evidence that the colloid
gelofusine produces a greater effect on cardiac output than an equivalent volume of of
saline, but it is unclear if this effect is replicated in the microvasculature.
We will test the hypotheses: (1) cardiac output and stroke volume as measured by ODM are
determinants of visceral microvascular blood flow (2) visceral microvascular blood flow in
elderly individuals is more closely determined by stroke volume (3) gelofusine produces a
greater increase in microvascular blood flow than the same volume of normal saline.
;
Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05001152 -
Taste Assessment of Ozanimod
|
Phase 1 | |
| Completed |
NCT05029518 -
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
|
Phase 1 | |
| Completed |
NCT04493255 -
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
|
Phase 1 | |
| Completed |
NCT03457649 -
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00995891 -
Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
|
||
| Completed |
NCT05043766 -
Evaluation of Oral PF614 Relative to OxyContin
|
Phase 1 | |
| Completed |
NCT05050318 -
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
|
Phase 4 | |
| Completed |
NCT04466748 -
A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT00746733 -
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
|
Phase 1 | |
| Recruiting |
NCT05929651 -
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
|
Phase 4 | |
| Completed |
NCT05954039 -
Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect
|
N/A | |
| Completed |
NCT05045716 -
A Study of Subcutaneous Lecanemab in Healthy Participants
|
Phase 1 | |
| Active, not recruiting |
NCT02747927 -
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
|
Phase 3 | |
| Completed |
NCT05533801 -
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
|
Phase 1 | |
| Not yet recruiting |
NCT03931369 -
Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)
|
Phase 2 | |
| Completed |
NCT03279146 -
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT06027437 -
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
|
Phase 1 | |
| Recruiting |
NCT05619874 -
Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity
|
N/A | |
| Completed |
NCT05553418 -
Investigational On-body Injector Clinical Study
|
N/A | |
| Completed |
NCT04092712 -
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
|
Phase 1 |