Trials / Completed
CompletedNCT03530046
High Strong Ion Difference Fluid vs Hartmann's Solution on Acid-Base Status in Sepsis
A Double-Blind, Randomized Control Trial of Rapidly Infused High Strong Ion Difference Fluid Versus Hartmann's Solution on Acid-Base Status in Sepsis and Septic Shock Patients in the Emergency Department Hospital Pulau Pinang
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 162 (actual)
- Sponsor
- Clinical Research Centre, Malaysia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a research to study primarily the effect of rapidly infused high strong ion difference (SID) fluid vs Hartmann's solution in altering the pH and bicarbonate level of the patient, who is in sepsis with metabolic acidosis. Half of the study population gets high SID fluid, while the other half will get Hartmann's solution.
Detailed description
Balanced fluids are preferred in initial resuscitation of septic patients based on several recent studies. The Stewart's concept on acid-base balance predicts that high strong ion difference (SID) fluid thus will increase the pH level. High SID fluid are specially formulated by adding sodium bicarbonate into half saline solution, the resultant fluid contains sodium= 145mmol/L and chloride=70mmol/L (SID= 75) as compared to Hartmann's solution with the SID of 20.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | High SID fluid | The fluid will be given to the patient at a rate prescribed by the treating physician according to clinical response for a period of 2 hours or up to maximum 30ml/kg fluid is given, whichever is earlier. |
| COMBINATION_PRODUCT | Hartmann's solution | The fluid will be given to the patient at a rate prescribed by the treating physician according to clinical response for a period of 2 hours or up to maximum 30ml/kg fluid is given, whichever is earlier. |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2017-12-18
- Completion
- 2018-01-18
- First posted
- 2018-05-21
- Last updated
- 2018-05-30
Source: ClinicalTrials.gov record NCT03530046. Inclusion in this directory is not an endorsement.