Skip to content

The effects of hypertonic fluid administration in patients with severe sepsis or septic shock

The effects of hypertonic fluid administration on gastrointestinal perfusion and sublingual microcirculation, in patients with severe sepsis or septic shock.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000259448
Enrollment
24
Registered
2007-05-15
Start date
2007-06-22
Completion date
2008-12-19
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients with severe sepsis (infection) frequently die. Sepsis interferes with the clotting and inflammatory systems and affects the heart, blood pressure as well as tissue oxygenation of the body. Vigorous fluid administration can restore the volume necessary to ensure blood and oxygen are carried around the body but may not be sufficient for good tissue perfusion. Hypertonic fluid which has a higher concentration of salt, is thought to both increase heart function and improve the flow of blood and oxygen into the micro tissues that supply the body. It is also thought to improve immune function. In this study we hope to randomise 24 eligible Intensive Care patients with severe sepsis, into two groups; a control group which will receive 500mls of 6% HES solution and the treatment group which will receive 250mls of Hyperhes hypertonic fluid. A variety of invasive and non-invasive measurements and blood tests will be taken over a six hour period. Demographic data and illness severity scores will be recorded as well as usual haemodynamic measures and recordings for seriously ill patients. Statistical analysis using standard techniques, will be done on SPSS version 10.0 Hyperhes, evaluated in previous studies, is regarded as a safe and well tolerated treatment for shock.

Interventions

Intervention: iv infusion over 15 minutes of 250 mls hyperhaes (7.2% NaCl [Sodium Chloride] / 6% Hydroxy Ethyl Starch).

Sponsors

Dr Frank van Haren
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients with severe sepsis or septic shock and need for fluid resuscitation (stroke volume variation > 12% or by clinical judgment)

Exclusion criteria

Pregnancy, hyponatremia (serum sodium level < 130 mmol/l), hypernatremia (serum sodium level > 150 mmol/l), arrhythmias, myocardial infarction < 1 month prior to study

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 28, 2026