BridgeMD
Compares treatment options for Sepsis
Official title Gelaspan vs Crystalloid Therapy in Sepsis
ClinicalTrials.gov ID: NCT07172451
What this study is testing
What is Balanced Gelatin Solution?
Balanced Gelatin Solution is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sepsis.
Also referred to as Succinylated Gelatin 4%, Gelatin Infusion.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this randomized clinical trial is to evaluate whether balanced gelatin solution is more effective and safe than balanced crystalloid solution for perioperative fluid management in adults with sepsis undergoing emergency abdominal surgery. Sepsis often causes severe fluid loss from the bloodstream into tissues, leading to low blood pressure, impaired organ function, and the need for urgent fluid resuscitation.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years.
- Diagnosis of sepsis according to the Sepsis-3 definition, caused by intra-abdominal infection, and requiring emergency abdominal surgery for source...
- Sequential Organ Failure Assessment (SOFA-2) score ≥ 2 (determined by the most recent available clinical data) and blood lactate \> 2 mmol/L...
- Subject or legal representative can understand the study purpose and provide written informed consent.
You likely can't join if
- Received any dose of artificial colloids within 24 hours prior to randomization.
- Predicted mortality within 48 hours (ASA physical status class ≥ V).
- Atrial fibrillation or congestive heart failure.
- Severe Acute Respiratory Distress Syndrome (ARDS).
- Preoperative coagulation dysfunction or receiving anticoagulant therapy.
- Preoperative requirement for renal replacement therapy (long-term or intermittent, including hemodialysis or peritoneal dialysis).
See the full eligibility criteria
- Age ≥ 18 years.
- Diagnosis of sepsis according to the Sepsis-3 definition, caused by intra-abdominal infection, and requiring emergency abdominal surgery for source control.
- Sequential Organ Failure Assessment (SOFA-2) score ≥ 2 (determined by the most recent available clinical data) and blood lactate \> 2 mmol/L (measured within 6 hours prior to enrollment).
- Subject or legal representative can understand the study purpose and provide written informed consent.
- Received any dose of artificial colloids within 24 hours prior to randomization.
- Predicted mortality within 48 hours (ASA physical status class ≥ V).
- Atrial fibrillation or congestive heart failure.
- Severe Acute Respiratory Distress Syndrome (ARDS).
- Preoperative coagulation dysfunction or receiving anticoagulant therapy.
- Preoperative requirement for renal replacement therapy (long-term or intermittent, including hemodialysis or peritoneal dialysis).
- Acute burns exceeding 10% of the total body surface area.
- Severe hepatic impairment.
- Severe electrolyte disturbance.
- Pregnancy or breastfeeding.
- Known allergy to gelatin.
- Current participation in other treatment clinical trials.
- Other conditions that the investigator considers inappropriate for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Xuzhou, Jiangsu, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Tianjing, Tianjing, China
- Hangzhou, Zhejiang, China
- Wenzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Nanjing, Jiangsu, China; Suzhou, Jiangsu, China; Xuzhou, Jiangsu, China; Shanghai, Shanghai Municipality, China; Chengdu, Sichuan, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.