Kinetic Method to Detect Dehydration

NCT ID: NCT01062776

Last Updated: 2010-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-05-31

Brief Summary

1. The distribution and elimination of infusion fluids can be studied by volume kinetics, a mathematical method based on serial analysis of the blood hemoglobin concentration.

2. The hypothesis of the present study is that the elimination of infused fluid is retarded in the presence of dehydration, and that volume kinetics would therefore be capable of detecting dehydration in human subjects.

3. We induce dehydration by injection graded doses of furosemide (a diuretic drug) in healthy volunteers and the kinetics of an infusion of crystalloid fluid is compared to when the same volunteer receives the same fluid without being in a dehydrated state.

Detailed Description

1. Fifteen healthy male volunteers are subjected to 4 experiments. They drink 800 ml of water at 6:00 AM to make sure they are not dehydrated when the experiments begin.

2. On two occasions the volunteer receives, at 9:00 AM, an intravenous infusion of acetated Ringer´s solution being either 5 ml/kg or 10 ml/kg, over 15 min. The blood hemoglobin concentration is measured during 16 occasions during 120 min by invasive blood sampling and also non-invasively by a pulse oximeter (Masimo´s Radical 7).

3. On two other occasions, the infusions are preceded for 2 hours of deliberate dehydration. Doses of furosemide 5 mg are repeated 3-4 times with the goal of creating dehydration amounting to approximately 2 liters of fluid. Excreted urine is collected and the volume measured.

4. The kinetics of each infusion is calculated by volume kinetics, and the data compared pairwise from the experiments with and those without dehydration.

5. The accuracy and precision of the non-invasive monitoring of Hgb can be determined.

6. The study is ended with that the Hgb response between the lying and sitting position is compared and with that the fluid balance is restored by ingestion of water.

7. Experiments are performed in the Department of Intensive Care at Linköping University Hospital, Sweden.

Conditions

Dehydration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

5 ml/kg of fluid, no dehydration

Volunteers receive an intravenous infusion of acetated Ringers solution over 15 min without preceding deliberate dehydration with furosemide.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

No dehydration is induced

10 ml/kg of fluid, no dehydration

Volunteers receive an intravenous infusion of acetated Ringers solution over 15 min without preceding deliberate dehydration with furosemide.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

No dehydration is induced

5 ml/kg of fluid, dehydration

Volunteers receive an intravenous infusion of 5 ml/kg acetated Ringers solution over 15 min after being dehydrated with furosemide.

Group Type: EXPERIMENTAL

Dehydration

Intervention Type: BIOLOGICAL

Furosemide 5 mg is given intravenously over 2 hours until approximately 2 liters of body fluid is lost.

10 ml/kg of fluid, dehydration

Volunteers receive an intravenous infusion of 10 ml/kg acetated Ringers solution over 15 min after being dehydrated with furosemide.

Group Type: EXPERIMENTAL

Dehydration

Intervention Type: BIOLOGICAL

Furosemide 5 mg is given intravenously over 2 hours until approximately 2 liters of body fluid is lost.

Interventions

Dehydration

Furosemide 5 mg is given intravenously over 2 hours until approximately 2 liters of body fluid is lost.

Intervention Type: BIOLOGICAL

Placebo

No dehydration is induced

Intervention Type: BIOLOGICAL

Other Intervention Names

Furosemide för intravenous administration; Acetated Ringer´s solution; Acetated Ringer´s solution

Eligibility Criteria

Inclusion Criteria

• Healthy male.

Exclusion Criteria

• Disease for which daily medication is required.
• Poor peripheral perfusion; defined as a perfusion index, as measured by Masimo´s Radical 7, of 2 or less.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sodertalje Hospital

OTHER

Sponsor Role: lead

Responsible Party

Södertälje Hospital

Principal Investigators

Robert G Hahn, MD, PhD

Role: STUDY_DIRECTOR

Södertälje Hospital

Locations

Department of Intensive Care, University hospital, Linköping, Sweden

Linköping, Linköping, Sweden

Countries

Sweden

References

Hahn RG, Wuethrich PY, Zdolsek JH. Can perioperative hemodilution be monitored with non-invasive measurement of blood hemoglobin? BMC Anesthesiol. 2021 May 6;21(1):138. doi: 10.1186/s12871-021-01351-4.

Reference Type: DERIVED

PMID: 33957864 (View on PubMed)

Other Identifiers

M114-09

Identifier Type: -

Identifier Source: org_study_id