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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High SID fluid | Experimental | Group 1: half-normal saline with addition of 75mEq/L sodium bicarbonate |
|
| Hartmann's solution | Active Comparator | Group 2: Hartmann's Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High SID fluid | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| pH change | 2 hours | |
| bicarbonate level change | mmol/L | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Lactate level difference | percentage | 2 hours |
| Development of pulmonary edema | 48 hours | |
| 30 days all-cause mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chunchiat Yeoh, MD | Emergency Department, Hospital Pulau Pinang | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 15, 2017 | May 27, 2018 | SAP_002.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 15, 2017 | May 27, 2018 | Prot_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 15, 2017 | May 27, 2018 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Hartmann's solution | Combination Product | 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. |
|
| 30 days |
| Length of stay | 90 days |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |