Clinical trial NCT01539798: Body Composition and Serum Biochemistry After Intravenous Infusion or Oral Intake of Saline in Healthy Volunteers
Official title: Changes in Body Composition, Hematological Parameters, and Serum Biochemistry and After Rapid Intravenous Infusion or Oral Intake of 2L of 0.9% Saline Solution in Young Healthy Volunteers. A Randomized Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edema
Perioperative/Postoperative Complications
Keywords: Saline solution
Sodium Chloride
Hypoalbuminemia
Weight Gain
Lead sponsor: Federal University of Mato Grosso
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The investigators conducted a cross-over study to compare the response of healthy young volunteers to a rapid oral intake or intravenous infusion of 0.9% saline solution on the body composition, serum electrolytes, albumin, and hematological parameters.

The investigators hypothesized that these parameters will differently adapt depending on the route of infusion

Detailed description: This was a cross over study including ten healthy young males (18-26 years old) with no acute or chronic illness for the last 3 months previously. They were not using any either medications or illicit drugs. Based on their body mass index (BMI) they were neither considered obese nor malnourished (BMI ranged from 22 to 27 kg/m2). They underwent the study after giving written informed consent. The study was approved by the Committee of Ethics in Research of the Julio Muller Hospital (862/CEP-HUJM/2010; Federal University of Mato Grosso, Cuiaba, Brazil). In two separate moments, all participants received in random order 2L of 0.9% saline by either the forearm vein or oral intake as follows.

Procedures The ten volunteers were fasted from midnight and they reported to the laboratory by 8-9 AM for the procedures. After having voided the bladder they were weighted to the nearest 0.1 kg and their heights were measured to the nearest 0.01 m with a estadiometer. Body mass was then calculated. Bioelectrical impedance analysis was performed with single-frequency (50 kHz) device (Bodystat 1500; Bodystat Ltd., Isle of Man, U.K.) using tetrapolar distal limb electrodes. TBW, fatty mass and lean body mass were calculated using regression equations programmed into the devices.

Firstly, a 12 gauge cannula was inserted the forearm and blood samples were collected for laboratory assays: hematocrit, hemoglobin, blood glucose, serum electrolytes (sodium, potassium, chloride and bicarbonate), albumin, creatinine, and osmolality. The volume of the urine output until 2h after the experiment was collected and measured.

Two liters of 0.9% saline were then infused over 1 hour into one of the forearm veins in all participants in supine position. An experienced anesthetist conducted the entire procedure at the laboratory. Blood pressure and pulse rate were taken every 30 minutes for 2h and the volunteers were not allowed to eat or drink during this period. After the infusion of the saline solution they were sent to void the bladder, were weighted again, and another blood sample was taken for the same assays. Another bioelectrical impedance analysis was carried out by the same manner. Two hours after the finish of the infusion they were asked to void the bladder again and the urinary output was registered.

The same volume of saline associated with a non-caloric flavor powder (Tang, Sao Paulo, Brazil) was orally ingested by the same volunteers 4 weeks after the first experiment, in the same room and following the same preparation as described. The blood samples were sent to the laboratory with a code that was broken in the end of the experiment and the data was put in a datasheet for statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Healthy young males (18-26 years) bearing no acute or chronic illness for the last 3 months previously to the experiment

Exclusion Criteria:

* Use of any drugs, tobacco, alcohol 2 months prior to the experiment. The investigators also planned to exclude those who for any reason do not comply with the protocols

Primary outcomes:
measure: Body Composition
timeFrame: 2 hours
Secondary outcomes:
measure: Serum electrolytes
timeFrame: 2 hours
Other outcomes:
Locations:
city: Cuiaba
country: Brazil
facility: Hospital Universitario Julio Mullar
state: Mato Grosso
Study officials:
affiliation: Federal University of Mato Grosso
name: Jose E Aguilar-Nascimento, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: