Trial Outcomes & Findings for The Effect of Acute Mild Dehydration on Blood Pressure Control (NCT NCT03560869)

Last Updated: 2021-01-27

Results Overview

Blood pressure variability (BPV) was calculated using standard deviation and using the average real variability index of blood pressure values. The average real variability index calculates the average of absolute differences between consecutive BP measurements and is thought to provide further prognostic value compared with traditional measures of BPV.

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

During experimental visits 1 and 2

Results posted on

2021-01-27

Participant Flow

All participants completed both conditions.

Participant milestones

Participant milestones
Measure	Normal Hydration Than Dehydration 14 participants consumed water to maintain proper hydration for three days prior to testing (visit 1). Seven to 60 days later, participants reduced water intake over three days and abstained from any water for the final 16 hours prior to testing (visit 2).	Dehydration Than Normal Hydration 21 participants reduced water intake over three days and abstained from any water for the final 16 hours prior to testing (visit 1). Seven to 60 days later, participants consumed water to maintain proper hydration for three days prior to testing (visit 2).
Overall Study STARTED	14	21
Overall Study COMPLETED	7	12
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Normal Hydration Than Dehydration 14 participants consumed water to maintain proper hydration for three days prior to testing (visit 1). Seven to 60 days later, participants reduced water intake over three days and abstained from any water for the final 16 hours prior to testing (visit 2).	Dehydration Than Normal Hydration 21 participants reduced water intake over three days and abstained from any water for the final 16 hours prior to testing (visit 1). Seven to 60 days later, participants consumed water to maintain proper hydration for three days prior to testing (visit 2).
Overall Study Withdrawal by Subject	3	4
Overall Study Screening failure	4	4
Overall Study Withdrawal by PI	0	1

Baseline Characteristics

The Effect of Acute Mild Dehydration on Blood Pressure Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=35 Participants All Study Participants
Age, Continuous	47 years STANDARD_DEVIATION 22 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: During experimental visits 1 and 2

Outcome measures

Outcome measures
Measure	Normal Hydration n=19 Participants Participants will consume water to maintain proper hydration for three days prior to testing. Hydration State: Hydration State	Dehydration n=19 Participants Participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing. Hydration State: Hydration State
Blood Pressure Variability	2.6 mmHg Standard Deviation 1.1	2.5 mmHg Standard Deviation 0.9

PRIMARY outcome

Timeframe: During experimental visits 1 and 2

Population: 4 adults were excluded from this analysis due to technical difficulties

Change in systolic blood pressure during the second-minute handgrip exercise minus compared to pre-exercise baseline (i.e., at rest).

Outcome measures

Outcome measures
Measure	Normal Hydration n=15 Participants Participants will consume water to maintain proper hydration for three days prior to testing. Hydration State: Hydration State	Dehydration n=15 Participants Participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing. Hydration State: Hydration State
Blood Pressure Reactivity - Handgrip Exercise	20 mmHg Standard Deviation 11	18 mmHg Standard Deviation 8

Adverse Events

Normal Hydration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dehydration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William B. Farquhar

University of Delaware

Phone: 302-831-6178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place