The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy
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|ClinicalTrials.gov Identifier: NCT04221672|
Recruitment Status : Recruiting
First Posted : January 9, 2020
Last Update Posted : January 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Terlipressin Adverse Reaction Ascites Hepatic Liver Failure Acute Kidney Injury||Drug: Terlipressin plus standard care Other: Standard care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study on the Effect of Terlipressin on Recovery of Liver Function After Hepatectomy: a Multicenter Randomized Controlled Study|
|Actual Study Start Date :||November 7, 2019|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Experimental: Terlipressin plus standard care
Immediately after hepatectomy, 1 mg terlipressin was given intravenously after hemostasis was achieved. After surgery, participants were routinely managed, and terlipressin were administrated at a dosage of 2 mg per day for 4 days.
Drug: Terlipressin plus standard care
All the participants received routine care after surgery. Intraoperative 1 mg, and 1 mg q12h from post-operative day 1 through day 4.
Other Name: terlipressin infusion plus routine care
Participants were not administrated with terlipressin during surgery and were routinely managed after surgery.
Other: Standard care
All the participants received routine care after surgery only.
Other Name: routine care
- The total abdominal drainage [ Time Frame: From post-operative day 1 to day 4. ]from postoperative day 1 through day 3.
- The incidence of post-hepatectomy liver failure [ Time Frame: From post-operative day 1 to day 30. ]based on the criteria of ISGLS 2011.
- The incidence of acute kidney injury [ Time Frame: From post-operative day 1 to day 30. ]defined as an absolute increase in serum creatinine (Cr) ≥ 0.3 mg/dl (26.5 μmol/L) and/or ≥ 50% from baseline
- The side effects of terlipressin [ Time Frame: From post-operative day 1 to day 30. ]the incidences of abdominal pain, diarrhea, headache, hyponatremia, and hypertension
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04221672
|Contact: Xiao-Dong Zhu, MD&PhDemail@example.com|
|Ruijin Hospital Affiliated To Shanghai Jiaotong University||Recruiting|
|Shanghai, Shanghai, China, 200025|
|Contact: Yongjun Chen|
|Zhongshan Hospital, Fudan University||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Xiao-Dong Zhu +862164041990 firstname.lastname@example.org|
|Principal Investigator: Hui-Chuan Sun, MD&PhD|
|Xinhua Hospital Affiliated to Shanghai Jiao Tong University||Recruiting|
|Shanghai, Shanghai, China, 200092|
|Contact: Jiandong Wang|
|Eastern Hepatobiliary Surgery Hospital, Second Military Medical University||Recruiting|
|Shanghai, Shanghai, China, 200438|
|Contact: Feng Shen|
|Principal Investigator:||Hui-Chuan Sun, MD&PhD||Fudan University|