Body Composition and Serum Biochemistry After Intravenous Infusion or Oral Intake of Saline in Healthy Volunteers

Perioperative/Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539798
• Other study ID #: valente_crossover
• Secondary ID: Oral versus iv s
• Status: Completed
• Phase: N/A
• First received: February 18, 2012
• Last updated: February 27, 2012
• Start date: August 2011
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: Federal University of Mato Grosso do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 26 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Edema
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Other:
• Oral saline
Ingestion of 2 L of 0.9% saline solution over 1h
• Intravenous saline
Infusion of 2L of 0.9% saline solution over 1h

Locations

Country	Name	City	State
Brazil	Hospital Universitario Julio Mullar	Cuiaba	Mato Grosso

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Mato Grosso do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition	. 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	2 hours	Yes
Secondary	Serum electrolytes	Blood samples were collected before infusion and 1h after for laboratory assays: hematocrit, hemoglobin, blood glucose, serum electrolytes (sodium, potassium, chloride and bicarbonate), albumin, creatinine, and osmolality.	2 hours	Yes