Ignite Creation Date:
2024-07-17 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467812
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-03-07
Brief Title:
Fluid Loading Countermeasures
Sponsor:
National Aeronautics and Space Administration NASA
Organization:
National Aeronautics and Space Administration NASA
Study Overview
Official Title:
Evaluating Efficacy of End-of-Mission Fluid Loading Protocols
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 31
Detailed 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 participants 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 doctors 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 participants 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 ie 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 participants body weight 1 mLkg body mass for men 08 mLkg 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 35 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 PIstudy lead if any off-nominal gastrointestinal symptoms occur in the day of the study visit after testing is completed
During the last 35 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 40
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 participants 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 ie 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 participants body weight 1 mLkg body mass for men 08 mLkg 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 35 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 PIstudy lead if any off-nominal gastrointestinal symptoms occur in the day of the study visit after testing is completed
During the last 35 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 40
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None