Postoperative HypoalbuminemiaPhase 2GOAINCT07119463
Effect of Goal-Oriented Albumin Infusion on Postoperative Complication Management in Gastric Cancer Surgery
A Phase 2 study testing Human Serum Albumin Infusion for LAT Group and Human Serum Albumin Infusion for HAT Group in people with Postoperative Hypoalbuminemia and Postoperative Complications, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This study aims to evaluate the impact of goal-oriented albumin infusion on short-term postoperative outcomes in gastric cancer patients. It is a single-center, prospective, non-randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Hypoalbuminemia, Postoperative Complications, Gastric Cancer
- What is being tested?
- Human Serum Albumin Infusion for LAT Group and Human Serum Albumin Infusion for HAT Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2024to 1 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age range: 18 to 80 years old, suitable for patients undergoing gastric cancer surgery.
- Gastric cancer diagnosis: gastric cancer patients confirmed by pathology, regardless of pathological type.
- Cancer staging: Patients with preoperative CT assessment of TNM stage I to III and undergoing laparoscopic gastric cancer surgery or open gastric cancer surgery can be included.
- Preoperative nutritional status: serum albumin level ≥ 30g/L, NRS-2002 score ≤ 2.
- Type of surgery: patients who undergo any radical gastric cancer surgery (no restriction on surgical type, covering partial gastrectomy, total gastrectomy, etc.).
- The patient gave informed consent to this study and signed the corresponding informed consent form.
- ASA classification I-III.
- ECOG score ≤ 2
Who cannot join
- Preoperative acute infection: Acute infection or acute complications (such as pneumonia, urinary tract infection, gastrointestinal bleeding, perforation, obstruction, etc.) have been diagnosed before surgery.
- Immunosuppressed patients: such as long-term use of immunosuppressants (such as glucocorticoids), organ transplant patients, or those who have been diagnosed with HIV infection.
- Serious basic diseases: such as severe liver insufficiency (Child Pugh class B or C), renal insufficiency (serum creatinine>133umol/L), severe cardiac insufficiency (NYHA class III and above), severe pulmonary insufficiency (preoperative blood gas analysis PaO2 ≤ 60mmHg).
- Patients with a history of albumin allergy.
- Intraoperative blood loss is greater than 500ml.
- Preoperative hemoglobin <70g/L.
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- Receive neoadjuvant radiotherapy before surgery.
- Patients who require combined organ resection.
- Patients who are found to have distant metastasis during intraoperative exploration, or who can not undergo radical resection.
- Withdrawal Criteria:
- 1) During the trial, the subjects suffered severe allergic reactions due to albumin infusion, such as acute anaphylactic shock, airway edema, hypotension, etc., and were not suitable for continued use of albumin. 2) If the subject clearly expresses his unwillingness to continue participating in the experiment due to personal reasons, even if his physical condition allows continued intervention, respect the patient's wishes and terminate his participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130021
Yuchen Guo, Ph.D., +8613630598312, guoyuchen8688@live.com
About this study
Official title: The Application and Effect of Goal-oriented Albumin Infusion in the Control of Postoperative Complications in Patients With Gastric Cancer - a Single-center Prospective Non- Randomized Controlled Study
This study aims to evaluate the impact of goal-oriented albumin infusion on short-term postoperative outcomes in gastric cancer patients. It is a single-center, prospective, non-randomized controlled study. Patients are divided into two groups: the experimental group receives albumin infusion when serum albumin levels fall below 25 g/L, while the control group receives albumin infusion when levels fall below 30 g/L. The primary endpoint is the incidence of complications graded Clavien-Dindo III or above within 30 days post-surgery. Secondary endpoints include nutritional recovery, gastrointestinal function recovery, hospital stay duration, and overall complication rates. The study seeks to optimize perioperative albumin management strategies and improve clinical outcomes.
Read the detailed description
Detailed Description:
This study evaluates the application and impact of goal-oriented albumin infusion in managing postoperative complications in gastric cancer patients. It is designed as a single-center, prospective, non-randomized controlled trial. The study population includes adult patients (18-80 years) undergoing radical gastric cancer surgery. Patients are divided into two groups:
Experimental Group: Albumin infusion is initiated when serum albumin levels fall below 25 g/L, aiming to maintain levels above this threshold.
Control Group: Albumin infusion is initiated when serum albumin levels fall below 30 g/L, maintaining levels above this threshold.
The primary endpoint is the incidence of complications graded Clavien-Dindo III or above within 30 days postoperatively. Secondary endpoints include nutritional status recovery (albumin levels within the first 7 days), hospital stay duration, gastrointestinal recovery (first flatus and bowel movement), and overall complication rates.
This study dynamically monitors albumin levels and evaluates the effects of different infusion standards on short-term postoperative outcomes. By analyzing these outcomes, the research aims to provide evidence-based recommendations for optimizing perioperative albumin management strategies in gastric cancer patients.
Albumin infusions are conducted following established protocols, with dosage calculated based on the patient's serum albumin levels and weight. Strict inclusion and exclusion criteria ensure participant safety and study validity. Adverse events are monitored closely, and any serious events are reported to the ethics committee promptly.
Data will be collected using electronic case report forms (eCRFs) and analyzed using appropriate statistical methods, including propensity score matching and multivariable regression, to control for potential confounding factors. The study's findings will contribute to improving postoperative care in gastric cancer patients.
- Being tested
- Human Serum Albumin Infusion for LAT Group, Human Serum Albumin Infusion for HAT Group
- Keywords
- Gastric Cancer, Postoperative Hypoalbuminemia, Albumin Infusion, Goal-Oriented Therapy, Postoperative Complications, Clavien-Dindo Classification, Nutritional Support
- Medical subject headings
- Postoperative Complications, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Serum Albumin Infusion for LAT GroupDrug
Participants in this group will receive human serum albumin infusion when their serum albumin level falls below 25 g/L. The infusion is goal-oriented, with the aim of maintaining albumin levels above 25 g/L during the postoperative period. The dose is calculated based on the albumin deficit and patient weight to ensure optimal therapeutic effect.
Human Serum Albumin Infusion for HAT GroupDrug
Participants in this group will receive human serum albumin infusion when their serum albumin level falls below 30 g/L. The intervention aims to maintain albumin levels above 30 g/L during the postoperative period. The dose is similarly calculated based on the albumin deficit and patient weight.
| Study group | Role | What they receive |
|---|---|---|
| Low Albumin Threshold Group（25g/L）（LAT Group） | Experimental | Participants in this group will receive albumin infusion when serum albumin levels fall below 25 g/L during the postoperative period. The intervention aims to maintain serum albumin levels above this threshold to evaluate its impact on complications and recovery. Receives: Drug: Human Serum Albumin Infusion for LAT Group |
| High Albumin Threshold Group (30 g/L)(HAT Group) | Active comparator | Participants in this group will receive albumin infusion when serum albumin levels fall below 30 g/L during the postoperative period. This group serves as the control to compare the effects of a higher albumin threshold on complications and recovery. Receives: Drug: Human Serum Albumin Infusion for HAT Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Complications (Clavien-Dindo Grade III or Above)
The primary outcome measure is the incidence of severe postoperative complications graded as Clavien-Dindo Grade III or above. These complications include those requiring surgical, endoscopic, or radiological intervention, or resulting in life-threatening conditions or mortality. The measure aims to compare the effects of two different albumin infusion thresholds (25 g/L vs. 30 g/L) on the rate of severe complications within the study period.
Measured: 30 Days Post-Surgery
Secondary outcomes (4)
Serum Albumin Levels Post-Surgery
The change in serum albumin levels within the first 7 days post-surgery will be measured to assess the effectiveness of goal-oriented albumin infusion in maintaining adequate protein levels. This measure will help evaluate nutritional recovery and the physiological impact of the intervention.
Measured: 7 Days Post-Surgery
Length of Hospital Stay
Postoperative length of hospital stay, measured in days from the day of surgery to the day of discharge.
Measured: From the day of surgery to the day of discharge (up to 30days)
Gastrointestinal Recovery
The time to first flatus and bowel movement after surgery will be measured from postoperative day 1 to the day of discharge, to evaluate the recovery of gastrointestinal function and the influence of different albumin thresholds on postoperative recovery.
Measured: Postoperative Day 1 to Day of Discharge (approximately Day 7）
Overall Postoperative Complication Rate
The overall rate of postoperative complications, including all Clavien-Dindo grades (I to V), will be recorded and analyzed. This measure aims to assess the broader impact of goal-oriented albumin infusion on postoperative outcomes across all severity levels.
Measured: 30 Days Post-Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start29 Oct 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HypoalbuminemiaStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuchen Guo, Ph.D., The First Hospital of Jilin University
- Investigators
- Yuchen Guo, Ph.D., Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119463
- Sponsor's protocol ID
- GOAI
- Acronym
- GOAI
- Status last verified
- Aug 2025
- First submitted
- 19 Jun 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If other researchers can provide valid reasons or demonstrate a need for additional collaboration, we may consider to share the data upon their request after we complete our study.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application and Effect of Goal-oriented Albumin Infusion in the Control of Postoperative Complications in Patients With Gastric Cancer - a Single-center Prospective Non- Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07119463
- Acronym / sponsor ID
- GOAI / GOAI
- Keywords
- Gastric Cancer, Postoperative Hypoalbuminemia, Albumin Infusion, Goal-Oriented Therapy, Postoperative Complications, Clavien-Dindo Classification, Nutritional Support
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 Aug 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.
This study aims to evaluate the impact of goal-oriented albumin infusion on short-term postoperative outcomes in gastric cancer patients. It is a single-center, prospective, non-randomized controlled study. Patients are divided into two groups: the experimental group receives albumin infusion when serum albumin levels fall below 25 g/L, while the control group receives albumin infusion when levels fall below 30 g/L. The primary endpoint is the incidence of complications graded Clavien-Dindo III or above within 30 days post-surgery. Secondary endpoints include nutritional recovery, gastrointestinal function recovery, hospital stay duration, and overall complication rates. The study seeks to optimize perioperative albumin management strategies and improve clinical outcomes.
Detailed description
Detailed Description:
This study evaluates the application and impact of goal-oriented albumin infusion in managing postoperative complications in gastric cancer patients. It is designed as a single-center, prospective, non-randomized controlled trial. The study population includes adult patients (18-80 years) undergoing radical gastric cancer surgery. Patients are divided into two groups:
Experimental Group: Albumin infusion is initiated when serum albumin levels fall below 25 g/L, aiming to maintain levels above this threshold.
Control Group: Albumin infusion is initiated when serum albumin levels fall below 30 g/L, maintaining levels above this threshold.
The primary endpoint is the incidence of complications graded Clavien-Dindo III or above within 30 days postoperatively. Secondary endpoints include nutritional status recovery (albumin levels within the first 7 days), hospital stay duration, gastrointestinal recovery (first flatus and bowel movement), and overall complication rates.
This study dynamically monitors albumin levels and evaluates the effects of different infusion standards on short-term postoperative outcomes. By analyzing these outcomes, the research aims to provide evidence-based recommendations for optimizing perioperative albumin management strategies in gastric cancer patients.
Albumin infusions are conducted following established protocols, with dosage calculated based on the patient's serum albumin levels and weight. Strict inclusion and exclusion criteria ensure participant safety and study validity. Adverse events are monitored closely, and any serious events are reported to the ethics committee promptly.
Data will be collected using electronic case report forms (eCRFs) and analyzed using appropriate statistical methods, including propensity score matching and multivariable regression, to control for potential confounding factors. The study's findings will contribute to improving postoperative care in gastric cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Albumin Threshold Group（25g/L）（LAT Group） | Experimental | Drug: Human Serum Albumin Infusion for LAT GroupParticipants in this group will receive albumin infusion when serum albumin levels fall below 25 g/L during the postoperative period. The intervention aims to maintain serum albumin levels above this threshold to evaluate its impact on complications and recovery. |
| High Albumin Threshold Group (30 g/L)(HAT Group) | Active comparator | Drug: Human Serum Albumin Infusion for HAT GroupParticipants in this group will receive albumin infusion when serum albumin levels fall below 30 g/L during the postoperative period. This group serves as the control to compare the effects of a higher albumin threshold on complications and recovery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age range: 18 to 80 years old, suitable for patients undergoing gastric cancer surgery.
- Gastric cancer diagnosis: gastric cancer patients confirmed by pathology, regardless of pathological type.
- Cancer staging: Patients with preoperative CT assessment of TNM stage I to III and undergoing laparoscopic gastric cancer surgery or open gastric cancer surgery can be included.
- Preoperative nutritional status: serum albumin level ≥ 30g/L, NRS-2002 score ≤ 2.
- Type of surgery: patients who undergo any radical gastric cancer surgery (no restriction on surgical type, covering partial gastrectomy, total gastrectomy, etc.).
Key exclusion criteria (11 listed)
- Preoperative acute infection: Acute infection or acute complications (such as pneumonia, urinary tract infection, gastrointestinal bleeding, perforation, obstruction, etc.) have been diagnosed before surgery.
- Immunosuppressed patients: such as long-term use of immunosuppressants (such as glucocorticoids), organ transplant patients, or those who have been diagnosed with HIV infection.
- Serious basic diseases: such as severe liver insufficiency (Child Pugh class B or C), renal insufficiency (serum creatinine>133umol/L), severe cardiac insufficiency (NYHA class III and above), severe pulmonary insufficiency (preoperative blood gas analysis PaO2 ≤ 60mmHg).
- Patients with a history of albumin allergy.
- Intraoperative blood loss is greater than 500ml.
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 |
|---|---|---|
| Human Serum Albumin Infusion for LAT GroupParticipants in this group will receive human serum albumin infusion when their serum albumin level falls below 25 g/L. The infusion is goal-oriented, with the aim of maintaining albumin levels above 25 g/L during the postoperative period. The dose is calculated based on the albumin deficit and patient weight to ensure optimal therapeutic effect. | Drug | Low Albumin Threshold Group（25g/L）（LAT Group） |
| Human Serum Albumin Infusion for HAT GroupParticipants in this group will receive human serum albumin infusion when their serum albumin level falls below 30 g/L. The intervention aims to maintain albumin levels above 30 g/L during the postoperative period. The dose is similarly calculated based on the albumin deficit and patient weight. | Drug | High Albumin Threshold Group (30 g/L)(HAT Group) |
Primary outcome
Incidence of Postoperative Complications (Clavien-Dindo Grade III or Above)
Time frame: 30 Days Post-Surgery
The primary outcome measure is the incidence of severe postoperative complications graded as Clavien-Dindo Grade III or above. These complications include those requiring surgical, endoscopic, or radiological intervention, or resulting in life-threatening conditions or mortality. The measure aims to compare the effects of two different albumin infusion thresholds (25 g/L vs. 30 g/L) on the rate of severe complications within the study period.
4 secondary outcomes
Serum Albumin Levels Post-Surgery
Time frame: 7 Days Post-Surgery
Length of Hospital Stay
Time frame: From the day of surgery to the day of discharge (up to 30days)
Gastrointestinal Recovery
Time frame: Postoperative Day 1 to Day of Discharge (approximately Day 7）
Overall Postoperative Complication Rate
Time frame: 30 Days Post-Surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Yes. If other researchers can provide valid reasons or demonstrate a need for additional collaboration, we may consider to share the data upon their request after we complete our study.
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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.
Yuchen Guo, Ph.D. principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human Serum Albumin Infusion for LAT Group and Human Serum Albumin Infusion for HAT Group in people with Postoperative Hypoalbuminemia and Postoperative Complications, run by The First Hospital of Jilin University at 1 site in China.
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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 13 Aug 2025. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuchen Guo, Ph.D. (0086+13630598312, guoyuchen8688@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Complications (Clavien-Dindo Grade III or Above) (time frame: 30 Days Post-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 13 Aug 2025.