Clinical Effects of Ringers Lactate Versus Sterofundin/ Plasmalyte Solution in Patients With Sepsis
NCT ID: NCT07239713
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
82 participants
INTERVENTIONAL
2025-11-15
2026-06-15
Brief Summary
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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.
Detailed Description
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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:
1. Does the choice of fluid produce different outcomes in this patient population?
2. If yes, then which fluid produces better outcomes?
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ringer's Lactate Group
This group will receive RInger's Lactate as maintenance fluid.
Ringer's Lactate Crystalloid Solutions
A balanced crystalloid solution containing sodium, potassium, calcium, chloride, and lactate as a buffer.
Used at a standard maintenance rate for adult postoperative patients.
Steroundin Group
This group will receive Sterofundin as maintenance fluid.
Sterofundin (Bolus of crystalloids)
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.
Interventions
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Ringer's Lactate Crystalloid Solutions
A balanced crystalloid solution containing sodium, potassium, calcium, chloride, and lactate as a buffer.
Used at a standard maintenance rate for adult postoperative patients.
Sterofundin (Bolus of crystalloids)
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.
Eligibility Criteria
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Inclusion Criteria
* ASA 1 to 4
* Diagnosis of sepsis (qSOFA score 2 or more)
Exclusion Criteria
* Patients requiring renal replacement therapy prior to enrolment
* Patients with suspected poisoning
* Pregnant women
* Patients having solitary kidney
18 Years
80 Years
ALL
No
Sponsors
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CMH Lahore Medical College and Institute of Dentistry
OTHER
Responsible Party
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Principal Investigators
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Syed A Jafri, MBBS
Role: STUDY_CHAIR
Combined military hospital lahore
Locations
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Combined Military Hospital Lahore
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Brig. Syed Asadullah Jafri
Role: primary
Other Identifiers
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563/2024
Identifier Type: -
Identifier Source: org_study_id