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The goal of this clinical trial is to compare the clinical effects of using Ringer's Lactate and Sterofundin/ Plasmalyte as maintenance fluids in adult patients who have undergone abdominal surgery and are septic.
The primary outcome will be the change in serum lactate levels. Secondary outcomes will include renal function parameters, qSOFA scores, and the incidence of postoperative complications within the first 72 hours following surgery.
The goal of this clinical trial is to compare the clinical effects of using Ringer's Lactate and Sterofundin/PlasmaLyte as maintenance fluids in adult patients who have undergone abdominal surgery and are septic.
The primary outcome will be the change in serum lactate levels. Secondary outcomes will include renal function parameters, qSOFA scores, and the incidence of postoperative complications within the first 72 hours following surgery.
The main questions it aims to answer are:
Enrolled patients will be randomly assigned Ringer's Lactate or Sterofundin for intravenous infusion. The volume, infusion rate and additive content will be determined by the treating clinicians. The intervention will last for 72 hours after patients' enrolment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ringer's Lactate Group | Active Comparator | This group will receive RInger's Lactate as maintenance fluid. |
|
| Steroundin Group | Experimental | This group will receive Sterofundin as maintenance fluid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ringer's Lactate Crystalloid Solutions | Other | A balanced crystalloid solution containing sodium, potassium, calcium, chloride, and lactate as a buffer. Used at a standard maintenance rate for adult postoperative patients. |
| Measure | Description | Time Frame |
|---|---|---|
| serum lactate | Measurement: Serum lactate levels will be measured from blood samples. Method: Standard laboratory assays will be used to quantify lactate concentration. Purpose: To assess the effect of maintenance fluids (Ringer's Lactate vs. Sterofundin) on lactate clearance and tissue perfusion in septic adult patients following abdominal surgery. Units: mmol/L | Samples will be collected at baseline (preoperatively or immediately postoperatively) and at predefined intervals during the postoperative period (e.g., 24 and 48 hours after surgery). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khadija Dr. Zubair, MBBS | Contact | +923211403262 | dr.khadijazubair97@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Syed A Jafri, MBBS | Combined military hospital lahore | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combined Military Hospital Lahore | Recruiting | Lahore | Punjab Province | 54000 | Pakistan |
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| Sterofundin (Bolus of crystalloids) | Other | A balanced, multi-electrolyte crystalloid solution containing acetate and malate as buffers instead of lactate. Designed to more closely match plasma electrolyte composition, with a lower chloride concentration than RL. |
|
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C052337 | sterofundin |
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