Cirrhosis, Liver, Upper Gastrointestinal Bleeding
Conditions
Keywords
liver cirrhosis, upper gastrointestinal bleeding, acute kidney injury, urinary IL-18
Brief summary
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.
Interventions
DRUGTerlipressin
Evaluate the effect of Terlipression on the occurance of acute kidney injury in patients with upper-gastroentestinal bleeding
DRUGSomatostatin
Somatostatin
Sponsors
Changhai Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of acute kidney injure | 48 hours | serum creatinine level increased by 26.5umol/L during 48hours or increased 50% compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hemostasis rate | 48 hours | Fecal occult blood negative or hemoglobin stable after 48H treatment |
| incidence of hepatic encephalopathy | 48 hours | Increased blood ammonia or directional force and computational power decrease after 48H treatment |
| The incidence of spontaneous bacterial peritonitis; | 48 hours | After 48H treatment, there is ascites and ascites has more than 20% nuclear cells |
| The incidence of hyponatremia | 48 hours | Serum sodium levels below 130mmol/l |
Countries
China
Outcome results
None listed