Congenital Heart DiseasesPhase 4NCT02527811
Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery
A Phase 4 study testing Ulinastatin in people with Congenital Heart Diseases, run by Techpool Bio-Pharma Co., Ltd. at 5 sites in China.
Trial summary
1. Explore the efficacy of Ulinastatin use in improving post-operative pulmonary insufficiency and safety in pediatric patients undergoing scheduled CPB open heart surgery to treat Complex Congenital Heart Disease 2. Read more about this study
- Who is it for?
- Ages 30 days to 4 years
- Conditions the study is for
- Congenital Heart Diseases
- What is being tested?
- Ulinastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 5 sitesChina
- Study dates
- Apr 2015to Dec 2018
- Phase
- Phase 4
- 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 30 days to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with Complex Congenital Heart Disease .
- Hospitalized children, both gender, aged ≥ 30 days to ≤ 4 years.
- Preoperative assessment meet with surgical condition.
- Without signs of Liver, Kidney, and Coagulatory dysfunction.
- Written informed consent form has been signed by the Legal Guardian.
Who cannot join
- Patients will accept minimally invasive surgery or palliative surgery, as well as Major Aortopulmonary Collateral Arteries (MAPCAs);
- Its decided that subject needs to undergo second surgery in a short period of time, or underwent other major surgery.
- Subjects with known hypersensitivity to study medication (Ulinastatin for Injection) or patients with highly allergic history.
- Though meeting the study inclusion criteria, the Legal Guardian reject to sign on informed consent. Or at the discretion of study investigator/coinvestigator that the subjects is not appropriate to be included in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
General Hospital of Guangzhou Millitary Command
Guangzhou, Guangdong, 510010
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623
Nanjing Children's Hospital
Nanjing, Jiangsu, 210000
Shanghai Children's Medical Center
Shanghai, 200127
Children's Hospital of Fudan University
Shanghai, 201102
About this study
Official title: A Randomized, Controlled Trial Evaluating Efficacy of Perioperative Organ Protection as Well as Safety of Ulinastatin Use in Pediatric Patients Undergoing Open Heart Surgery Through CPB to Treat Complex Congenital Heart Diseases
- Explore the efficacy of Ulinastatin use in improving post-operative pulmonary insufficiency and safety in pediatric patients undergoing scheduled CPB open heart surgery to treat Complex Congenital Heart Disease
- Explore the efficacy of Ulinastatin use in improving intraoperative hemodynamic instability as well as other post-operative organ recuperation and its impact on hospital stay \& cost
Read the detailed description
Pediatric patients diagnosed with Complex Congenital Heart Disease ready to accept scheduled open-heart surgery under cardiopulmonary bypass (CPB).
This study uses randomized (centralized randomization) \& controlled design with open label. Eligible subjects will be randomized to receive either study drug (Ulinastatin) or conventional treatment.
- Conditions
- Congenital Heart Diseases
- Being tested
- Ulinastatin
- Keywords
- ulinastatin, CPB, pediatric
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlinastatinDrug
Also called UTI, urinary trypsin inhibitor, bikunin
Ulinastatin will be diluted into saline solution and administered intravenously in the intraoperative and postoperative
| Study group | Role | What they receive |
|---|---|---|
| ulinastatin group | Experimental | the ulinastatin group will be administered as follows:Ulinastatin 30,000 unit/kg will be diluted into saline solution and administered intravenously in the surgery; Postoperative administration will be 30,000unit/kg divided into 3 regimens until leave ICU. Receives: Drug: Ulinastatin |
| control group | No intervention | patients of control group received conventional therapy,eg,General anesthetic drug and monitoring during the whole process of surgery;Mechanical ventilation and close monitoring to prevent and manage respiratory acidosis and alkalosis and so on. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic changes of arterial oxygen tension / inspired oxygen fraction (PaO2/FiO2) ratio
Dynamic changes of PaO2/FiO2 ratio will be observed in every 4 hours interval during post-operative ICU stay period
Measured: Participants will be followed for the duration of ICU, an expected average of 5 days
Secondary outcomes (6)
The time of the PaO2/ FiO2 Ratio ≥300 post surgery
Measured: Participants will be followed for the duration of ICU, an expected average of 5 days
The proportion of the PaO2/ FiO2 Ratio ≥300 post surgery
Measured: Participants will be followed for the duration of ICU, an expected average of 5 days
Monitoring arterial hydrogen ion concentration
Measured: Participants will be followed for the duration of ICU, an expected average of 5 days
Monitoring record of mean blood pressure
Measured: Intraoperative and Postoperative,an expected average of 6 days
Monitoring record of central venous pressure
Measured: Intraoperative and Postoperative,an expected average of 6 days
Analysis proinflammatory cytokines Interleukin 1
Measured: Preoperative and Postoperative on day1 ,day3 and day5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Techpool Bio-Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Children's Medical Center, Guangzhou Women and Children's Medical Center, Guangzhou General Hospital of Guangzhou Military Command, Nanjing Children's Hospital, Children's Hospital of Fudan University
- Responsible party
- Sponsor
- Investigators
- Wei Wang, MD, Study chair, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527811
- Sponsor's protocol ID
- GDTP-CDMA-201402
- Status last verified
- Jan 2018
- First submitted
- 18 Dec 2014
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Evaluating Efficacy of Perioperative Organ Protection as Well as Safety of Ulinastatin Use in Pediatric Patients Undergoing Open Heart Surgery Through CPB to Treat Complex Congenital Heart Diseases
- ClinicalTrials.gov ID
- NCT02527811
- Acronym / sponsor ID
- GDTP-CDMA-201402
- Conditions
- Congenital Heart Diseases
- Keywords
- ulinastatin, CPB, pediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Techpool Bio-Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Children's Medical Center, Guangzhou Women and Children's Medical Center, Guangzhou General Hospital of Guangzhou Military Command, Nanjing Children's Hospital, Children's Hospital of Fudan University
- Study start
- Apr 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Aug 2015 (estimated)
- 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.
- Explore the efficacy of Ulinastatin use in improving post-operative pulmonary insufficiency and safety in pediatric patients undergoing scheduled CPB open heart surgery to treat Complex Congenital Heart Disease
- Explore the efficacy of Ulinastatin use in improving intraoperative hemodynamic instability as well as other post-operative organ recuperation and its impact on hospital stay \& cost
Detailed description
Pediatric patients diagnosed with Complex Congenital Heart Disease ready to accept scheduled open-heart surgery under cardiopulmonary bypass (CPB).
This study uses randomized (centralized randomization) \& controlled design with open label. Eligible subjects will be randomized to receive either study drug (Ulinastatin) or conventional treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ulinastatin group | Experimental | Drug: Ulinastatinthe ulinastatin group will be administered as follows:Ulinastatin 30,000 unit/kg will be diluted into saline solution and administered intravenously in the surgery; Postoperative administration will be 30,000unit/kg divided into 3 regimens until leave ICU. |
| control group | No intervention | –patients of control group received conventional therapy,eg,General anesthetic drug and monitoring during the whole process of surgery;Mechanical ventilation and close monitoring to prevent and manage respiratory acidosis and alkalosis and so on. |
Who may qualify
- Ages
- 30 days to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children diagnosed with Complex Congenital Heart Disease .
- Hospitalized children, both gender, aged ≥ 30 days to ≤ 4 years.
- Preoperative assessment meet with surgical condition.
- Without signs of Liver, Kidney, and Coagulatory dysfunction.
- Written informed consent form has been signed by the Legal Guardian.
Key exclusion criteria (4 listed)
- Patients will accept minimally invasive surgery or palliative surgery, as well as Major Aortopulmonary Collateral Arteries (MAPCAs);
- Its decided that subject needs to undergo second surgery in a short period of time, or underwent other major surgery.
- Subjects with known hypersensitivity to study medication (Ulinastatin for Injection) or patients with highly allergic history.
- Though meeting the study inclusion criteria, the Legal Guardian reject to sign on informed consent. Or at the discretion of study investigator/coinvestigator that the subjects is not appropriate to be included in the study.
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 |
|---|---|---|
| UlinastatinAlso: UTI, urinary trypsin inhibitor, bikuninUlinastatin will be diluted into saline solution and administered intravenously in the intraoperative and postoperative | Drug | ulinastatin group |
Primary outcome
Dynamic changes of arterial oxygen tension / inspired oxygen fraction (PaO2/FiO2) ratio
Time frame: Participants will be followed for the duration of ICU, an expected average of 5 days
Dynamic changes of PaO2/FiO2 ratio will be observed in every 4 hours interval during post-operative ICU stay period
6 secondary outcomes
The time of the PaO2/ FiO2 Ratio ≥300 post surgery
Time frame: Participants will be followed for the duration of ICU, an expected average of 5 days
The proportion of the PaO2/ FiO2 Ratio ≥300 post surgery
Time frame: Participants will be followed for the duration of ICU, an expected average of 5 days
Monitoring arterial hydrogen ion concentration
Time frame: Participants will be followed for the duration of ICU, an expected average of 5 days
Monitoring record of mean blood pressure
Time frame: Intraoperative and Postoperative,an expected average of 6 days
Monitoring record of central venous pressure
Time frame: Intraoperative and Postoperative,an expected average of 6 days
Analysis proinflammatory cytokines Interleukin 1
Time frame: Preoperative and Postoperative on day1 ,day3 and day5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Wei Wang, MD study chair
Shanghai Children's Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ulinastatin in people with Congenital Heart Diseases, run by Techpool Bio-Pharma Co., Ltd. at 5 sites 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Dynamic changes of arterial oxygen tension / inspired oxygen fraction (PaO2/FiO2) ratio (time frame: Participants will be followed for the duration of ICU, an expected average of 5 days). 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 17 Jan 2018.