Fluid Loading Countermeasures

Healthy Clinical Trial

Official title:

Evaluating Efficacy of End-of-Mission Fluid Loading Protocols

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06467812
• Other study ID #: Study00000469
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 2024

Study information

• Verified date: August 2023
• Source: National Aeronautics and Space Administration (NASA)
• Contact: Jason R. Lytle, PhD
• Phone: 805-407-5038
• Email: jason.r.lytle[@]nasa.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of Fluid Loading Countermeasures is to determine how the volume of blood and of plasma (liquid part of blood) change during a normal day, how these are affected by drinking an additional amount of fluid either as water and salt tablets (as astronauts do) or an electrolyte beverage (similar to but tastes saltier than Gatorade®), and how altering the timing at which the additional fluid is consumed affects blood and plasma volume. This study observes how blood volume changes over ~9 hours of the day during 4 separate visits in healthy participants. During 1 visit participants will drink a small amount of water throughout the visit. During the other 3 study visits participants will drink the small amount of water plus either more water with salt tablets or an electrolyte solution. Consuming the additional fluids is called "fluid loading". This study is meant to simulate the food and fluid consumption of astronauts on landing day. The goal of this study is to determine the magnitude of plasma volume change that occurs with each condition of the protocol. (ICF 1.1, 3.1)

Description:

Upon arrival for each visit, participants will be told which study session they will be participating in that day. Food and water consumption as well as fluid loading will be timed throughout the day during other testing described below. Participants will be asked to empty their bladder, and body weight will be measured using a standard calibrated medical scale. Then, an intravenous (IV) catheter (a small plastic tube) will be inserted into a vein in the participant's arm. This IV catheter will remain in their arm for the duration of the study day. This is the same method that is used in a doctor's office or hospital. All blood samples will be obtained using the IV catheter in the arm.

Next, a test called Carbon Monoxide Re-Breathing (CORB) will be done to measure plasma volume, which is the liquid part of blood. A clip will be placed on the participant's nose so that they are breathing only through their mouth. Participants will breathe through a mouthpiece connected to a rebreathing circuit containing 100% oxygen, which is scrubbed by soda lime to remove carbon dioxide. After ~5 minutes, the first blood sample (~10 Milliliters [mL]) will be collected from an arm vein using the IV catheter. Thereafter, a small amount of carbon monoxide will be added into the breathing circuit, and the participant will breathe this mixture of carbon monoxide and oxygen for ~10 min. Then, a second ~10 mL blood sample will be obtained. Analysis of the blood samples (i.e., hematocrit, hemoglobin, and carboxyhemoglobin) will be used to calculate red blood cell mass, plasma volume, and total blood volume. The total amount of carbon monoxide will be determined based on the participant's body weight (1 mL/kg body mass for men; 0.8 mL/kg body mass for women), and this dose should result in no symptoms. Mild symptoms of carbon monoxide toxicity may occur at carboxyhemoglobin levels >10% but given the dose of carbon monoxide administered in this study, reaching this level is unlikely.

Participants will be seated for the duration of the study, except for short bathroom breaks allowed periodically during the study session. The volume of urine and the time of collection will be measured and recorded throughout the day. Participants will be provided food during the morning as well as water to drink during the first 5 hours of each visit. Meals will be like those typically consumed by astronauts on the International Space Station. During 3 of the visits, participants will be given additional fluids to drink on a set schedule (Fluid Loading). Participants will not be allowed to consume any fluids or food during the last 3.5 hours of the visit. Participants will be asked about the presence of gastrointestinal symptoms periodically throughout each study session. Additionally, we ask that participants report to the PI/study lead if any off-nominal gastrointestinal symptoms occur in the day of the study visit after testing is completed.

During the last 3.5 hours of each visit, 5 additional blood samples will be obtained (one each hour), used to calculate the change in plasma volume at each time point. Participant blood pressure and heart rate will be measured periodically throughout the day. (IRB protocol section 4.0)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• Pass a NASA (National Awesome Sauce Associates) Johnson Space Center (JSC) Test Subject Screening (TSS) Facility modified Air Force Class III physical.

Exclusion Criteria:

• Pregnant subjects will be excluded (a urine pregnancy screen will be made available to test subjects)

• Systemic diseases or current medications known to influence the cardiovascular system

• Renal disease

• Type II Diabetes

• Restrictive diet that would prevent subjects from consuming typical food eaten by astronauts. Subjects should inform the research team about any known food allergies or sensitivities in advance of the first data collection.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Salt Tablets
Three doses of 4 Salt Tablets (1gm) will be taken with 400mL of water on day 2 (1200ml total) between ~8am and ~12pm during the testing day, which runs from ~7am to ~3:30pm.
• Electrolyte Solution
Three doses of 400mL of the Electrolyte Solution dissolved in water (1200 mL total) will be consumed on day 3 between ~8am and ~12pm during the testing day, which runs from ~7am to ~3:30pm. On day 4 the Electrolyte Solution Single Bolus will be consumed in a single dose of 1200mL at ~12pm during the testing day. The ingredients are included below for the two flavors offered. Orange flavor: Water, Dextrose with Maltodextrin, Aspartame, Acesulfame Potassium, Sodium Citrate, Salt, Citric Acid, Maltodextrin, Natural Flavor, Calcium Phosphate, Contains less than 2% Of Ascorbic Acid (Vitamin C), Artificial Flavor, Artificial Color, Red 40, Yellow 5, BHA (Butylated Hydroxyanisole). Lemonade flavor: Water, Dextrose with Maltodextrin, Aspartame, Acesulfame Potassium, Sodium Citrate, Salt, Citric Acid, Calcium Phosphate, Maltodextrin, Contains less than 2% Of Ascorbic Acid (Vitamin C), Natural Flavor, Artificial Color, Yellow 5, BHA.

Locations

Country	Name	City	State
United States	NASA	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Aeronautics and Space Administration (NASA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Volume	Plasma volume measured using blood sample	8-9 hours
Primary	Fluid Balance	Urine output subtracted from fluid intake (mL)	8-9 hours
Primary	Gastrointestinal Distress	Open response self-reported symptoms	8-9 hours
Primary	Urine Volume	void-by-void urine output collected and measured (mL)	8-9 hours