Post Abdominal SurgeryNCT07239713
Clinical Effects of Ringers Lactate Versus Sterofundin/ Plasmalyte Solution in Patients With Sepsis
A study testing Ringer's Lactate Crystalloid Solutions and Sterofundin (Bolus of crystalloids) in people with Post Abdominal Surgery and Sepsis Abdominal, run by CMH Lahore Medical College and Institute of Dentistry at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Abdominal Surgery, Sepsis Abdominal
- What is being tested?
- Ringer's Lactate Crystalloid Solutions and Sterofundin (Bolus of crystalloids)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Underwent Abdominal Surgery and postoperative length of stay is more than 24 hours
- ASA 1 to 4
- Diagnosis of sepsis (qSOFA score 2 or more)
Who cannot join
- Patients with Renal failure/hepatic failure/severe metabolic acidosis
- Patients requiring renal replacement therapy prior to enrolment
- Patients with suspected poisoning
- Pregnant women
- Patients having solitary kidney
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Combined Military Hospital Lahore
Lahore, Punjab Province, 54000
About this study
Official title: Clinical Effects of Ringers Lactate Versus Sterofundin/Plasmalyte Solution in Surgical Adult Patients With Sepsis; a Comparative Study in ICU Patients
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.
Read the detailed description
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:
- Does the choice of fluid produce different outcomes in this patient population?
- 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
- Post Abdominal Surgery, Sepsis Abdominal
- Being tested
- Ringer's Lactate Crystalloid Solutions, Sterofundin (Bolus of crystalloids)
- Keywords
- Fluid therapy, Abdominal Surgery, Postoperative, Sepsis
- Medical subject headings
- Intraabdominal Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's Lactate Crystalloid SolutionsOther
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)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.
| Study group | Role | What they receive |
|---|---|---|
| Ringer's Lactate Group | Active comparator | This group will receive RInger's Lactate as maintenance fluid. Receives: Other: Ringer's Lactate Crystalloid Solutions |
| Steroundin Group | Experimental | This group will receive Sterofundin as maintenance fluid. Receives: Other: Sterofundin (Bolus of crystalloids) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start15 Nov 2025
- Primary completion15 May 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Lahore Medical College and Institute of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed A Jafri, MBBS, Study chair, Combined military hospital lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239713
- Sponsor's protocol ID
- 563/2024
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Ringers Lactate Versus Sterofundin/Plasmalyte Solution in Surgical Adult Patients With Sepsis; a Comparative Study in ICU Patients
- ClinicalTrials.gov ID
- NCT07239713
- Acronym / sponsor ID
- 563/2024
- Conditions
- Post Abdominal Surgery, Sepsis Abdominal
- Keywords
- Fluid therapy, Abdominal Surgery, Postoperative, Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- CMH Lahore Medical College and Institute of DentistryUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Does the choice of fluid produce different outcomes in this patient population?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ringer's Lactate Group | Active comparator | Other: Ringer's Lactate Crystalloid SolutionsThis group will receive RInger's Lactate as maintenance fluid. |
| Steroundin Group | Experimental | Other: Sterofundin (Bolus of crystalloids)This group will receive Sterofundin as maintenance fluid. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Underwent Abdominal Surgery and postoperative length of stay is more than 24 hours
- ASA 1 to 4
- Diagnosis of sepsis (qSOFA score 2 or more)
Key exclusion criteria (5 listed)
- Patients with Renal failure/hepatic failure/severe metabolic acidosis
- Patients requiring renal replacement therapy prior to enrolment
- Patients with suspected poisoning
- Pregnant women
- Patients having solitary kidney
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ringer's Lactate Crystalloid SolutionsA balanced crystalloid solution containing sodium, potassium, calcium, chloride, and lactate as a buffer. Used at a standard maintenance rate for adult postoperative patients. | Other | Ringer's Lactate Group |
| 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. | Other | Steroundin Group |
Primary outcome
serum lactate
Time frame: 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).
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed A Jafri, MBBS study chair
Combined military hospital lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ringer's Lactate Crystalloid Solutions and Sterofundin (Bolus of crystalloids) in people with Post Abdominal Surgery and Sepsis Abdominal, run by CMH Lahore Medical College and Institute of Dentistry at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum lactate (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.