Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Gelaspan vs Crystalloid Therapy in Sepsis

Efficacy and Safety of Balanced Gelatin Solution for Fluid Infusion in Sepsis Patients Undergoing Emergency Abdominal Surgery: A Multicenter, Adaptive Designed, Randomized Controlled Trial

Gelaspan vs Crystalloid Therapy in Sepsis (NCT07172451) is a Phase 4 interventional studying Sepsis and Intra-Abdominal Infections, sponsored by Shanghai Zhongshan Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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. Balanced gelatin, a colloid solution, may help maintain intravascular volume more effectively than crystalloid alone. In this study, participants are randomly assigned in a 1:1 ratio to receive either balanced gelatin or Ringer's acetate during surgery and in the first 24 hours afterward. All patients receive standardized anesthesia care, goal-directed fluid therapy, and protocolized use of vasoactive drugs. The main questions the study aims to answer are: * Does balanced gelatin reduce positive fluid balance within 24 hours after surgery? * Does it improve hemodynamic stability during the early postoperative period? * What effects does balanced gelatin have on kidney function, microcirculation, postoperative recovery, and other clinical outcomes? Participants will be followed throughout hospitalization and contacted again on postoperative day 28 and day 90 to assess survival, complications, and health-related quality of life. The trial is double-blind, meaning that patients, clinicians, and outcome assessors do not know which fluid is being used. An independent Data and Safety Monitoring Board will oversee patient safety during the study. The findings of this trial are expected to provide important evidence to guide perioperative fluid resuscitation strategies for septic patients undergoing emergency surgery.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 318 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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 interventional clinical trials. - Other conditions that the investigator considers inappropriate for inclusion. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion 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. Exclusion Criteria: * 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 interventional clinical trials. * Other conditions that the investigator considers inappropriate for inclusion.

Treatments Being Tested

DRUG

Balanced Gelatin Solution

Description: Balanced gelatin solution (4% succinylated gelatin in a balanced crystalloid carrier). Administered as the primary resuscitation fluid during the intraoperative period and may be continued into the first 24 postoperative hours if clinically indicated and available. Infusion follows a stroke volume-guided, goal-directed fluid therapy protocol. The total dose of the study fluid is capped at 30 mL/kg (ideal body weight) within 24 hours. If the maximum dose is reached or the study fluid is no longer available postoperatively, additional resuscitation is provided with Ringer's acetate solution.

DRUG

Acetate Ringer's Solution

Description: Acetate Ringer's solution, a balanced crystalloid, administered as the sole resuscitation fluid in patients with sepsis undergoing emergency abdominal surgery. Fluid therapy follows the same stroke volume-guided, goal-directed protocol as the experimental arm. This regimen is maintained throughout the intraoperative period and the first 24 postoperative hours to ensure the exclusion of any exogenous colloids or lactate-containing solutions. There is no upper limit for the total volume of crystalloid infusion.

Locations (9)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University General Hospital

Tianjing, Tianjing, China

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University (WMU)

Wenzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07172451), the sponsor (Shanghai Zhongshan Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07172451 clinical trial studying?

Who can participate in NCT07172451?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07172451?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07172451. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07172451. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.