Cirrhosis, LiverPhase 4NCT04358016
Terlipression Prevent Developing of Acute Kidney Injury During Upper-gastroentestinal Bleeding
A Phase 4 study testing Terlipressin and Somatostatin in people with Cirrhosis, Liver and Upper Gastrointestinal Bleeding, run by Changhai Hospital at 1 site in China.
Trial summary
The investigators studied the renal function index level in terlipressin treated cirrhotic patients with upper-gastrointestinal bleeding at different time point. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis, Liver, Upper Gastrointestinal Bleeding
- What is being tested?
- Terlipressin and Somatostatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Mar 2020
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosied as cirrhosis with upper gastrointestinal bleeding 18≤age≤70 Varicose vein rupture occurred within 24 hours, Without drug, endoscopy or interventional therapy Can read, understand and sign informed consent
Who cannot join
- Pregnant women, lactating women; Serious cardiovascular disease: history of acute cardiac infarction, heart block, heart failure, arterial hypertension(（SBP>170mmHg and/ or DBP>100mmHg） Occlusive lower extremity venous disease Asthma, chronic obstructive pulmonary disease Have serious or unable to control other organ diseases; Cerebrovascular disease; Age ≥70 years old Known to be allergic to therapeutic drugs Chronic kidney disease Weight ≤40kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Protection of Telipression on Developing of Acute Kidney Injury in Cirrhotic Patients With Upper-gastroentestinal Bleeding
The investigators studied the renal function index level in terlipressin treated cirrhotic patients with upper-gastrointestinal bleeding at different time point.
Read the detailed description
54 cirrhotic patients with uppre-gastrointestinal bleeding were entrolled and were distributed into terlipressin group and control group at 1:1 rate. Patients in Terlipressin group received 1mg/6h of terlipressin intravenously for 5 days, and patients in control group recerved 1mg/12h of Somatostatin intravenously for 5 days.
At enrollment, 24h,48h,72,and 1week, the renal function index level( serum creatinine,urine biochemistry and Urinary tubule injury index etc) were tested.
- Conditions
- Cirrhosis, Liver, Upper Gastrointestinal Bleeding
- Being tested
- Terlipressin, Somatostatin
- Keywords
- liver cirrhosis, upper gastrointestinal bleeding, acute kidney injury, urinary IL-18
- Medical subject headings
- Liver Cirrhosis, Gastrointestinal Hemorrhage, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Evaluate the effect of Terlipression on the occurance of acute kidney injury in patients with upper-gastroentestinal bleeding
SomatostatinDrug
Somatostatin
| Study group | Role | What they receive |
|---|---|---|
| terlipression | Experimental | terlipression 1mg；once every 6 hours；5days Receives: Drug: Terlipressin |
| Control | Active comparator | Somatostatin，3mg， once every 12 hours; 5 days Receives: Drug: Somatostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of acute kidney injure
serum creatinine level increased by 26.5umol/L during 48hours or increased 50% compared to baseline
Measured: 48 hours
Secondary outcomes (4)
hemostasis rate
Fecal occult blood negative or hemoglobin stable after 48H treatment
Measured: 48 hours
incidence of hepatic encephalopathy
Increased blood ammonia or directional force and computational power decrease after 48H treatment
Measured: 48 hours
The incidence of spontaneous bacterial peritonitis;
After 48H treatment, there is ascites and ascites has more than 20% nuclear cells
Measured: 48 hours
The incidence of hyponatremia
Serum sodium levels below 130mmol/l
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LiangXS, Changhai Hospital
- Investigators
- Xuesong Liang, Dr, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358016
- Sponsor's protocol ID
- LDWJPMF-102-1700
- Status last verified
- Nov 2019
- First submitted
- 15 Oct 2019
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protection of Telipression on Developing of Acute Kidney Injury in Cirrhotic Patients With Upper-gastroentestinal Bleeding
- ClinicalTrials.gov ID
- NCT04358016
- Acronym / sponsor ID
- LDWJPMF-102-1700
- Conditions
- Cirrhosis, Liver, Upper Gastrointestinal Bleeding
- Keywords
- liver cirrhosis, upper gastrointestinal bleeding, acute kidney injury, urinary IL-18
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 22 Apr 2020 (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 investigators studied the renal function index level in terlipressin treated cirrhotic patients with upper-gastrointestinal bleeding at different time point.
Detailed description
54 cirrhotic patients with uppre-gastrointestinal bleeding were entrolled and were distributed into terlipressin group and control group at 1:1 rate. Patients in Terlipressin group received 1mg/6h of terlipressin intravenously for 5 days, and patients in control group recerved 1mg/12h of Somatostatin intravenously for 5 days.
At enrollment, 24h,48h,72,and 1week, the renal function index level( serum creatinine,urine biochemistry and Urinary tubule injury index etc) were tested.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| terlipression | Experimental | Drug: Terlipressinterlipression 1mg；once every 6 hours；5days |
| Control | Active comparator | Drug: SomatostatinSomatostatin，3mg， once every 12 hours; 5 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosied as cirrhosis with upper gastrointestinal bleeding 18≤age≤70 Varicose vein rupture occurred within 24 hours, Without drug, endoscopy or interventional therapy Can read, understand and sign informed consent
Key exclusion criteria (1 listed)
- Pregnant women, lactating women; Serious cardiovascular disease: history of acute cardiac infarction, heart block, heart failure, arterial hypertension(（SBP>170mmHg and/ or DBP>100mmHg） Occlusive lower extremity venous disease Asthma, chronic obstructive pulmonary disease Have serious or unable to control other organ diseases; Cerebrovascular disease; Age ≥70 years old Known to be allergic to therapeutic drugs Chronic kidney disease Weight ≤40kg
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 |
|---|---|---|
| TerlipressinEvaluate the effect of Terlipression on the occurance of acute kidney injury in patients with upper-gastroentestinal bleeding | Drug | terlipression |
| SomatostatinSomatostatin | Drug | Control |
Primary outcome
incidence of acute kidney injure
Time frame: 48 hours
serum creatinine level increased by 26.5umol/L during 48hours or increased 50% compared to baseline
4 secondary outcomes
hemostasis rate
Time frame: 48 hours
incidence of hepatic encephalopathy
Time frame: 48 hours
The incidence of spontaneous bacterial peritonitis;
Time frame: 48 hours
The incidence of hyponatremia
Time frame: 48 hours
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 22 Apr 2020.
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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.
Xuesong Liang, Dr principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Terlipressin and Somatostatin in people with Cirrhosis, Liver and Upper Gastrointestinal Bleeding, run by Changhai Hospital 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 1 inclusion and 1 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 22 Apr 2020. 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 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?
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?
incidence of acute kidney injure (time frame: 48 hours). 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 22 Apr 2020.