Effect of LSD on Renal Function in Cirrhosis Patients With Portal Hypertension Bleeding (2-Year Follow-Up)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorNorthern Jiangsu People's Hospital

About this trial

Patients with liver cirrhosis often have impaired or at-risk kidney function due to the close link between liver and kidney (hepatorenal syndrome). Laparoscopic Splenectomy and Azygoportal Disconnection (LSD) is commonly used to treat Cirrhosis with Portal Hypertension Bleeding in these patients, but its impact on kidney function over 2 years is unclear. This study will follow patients undergoing laparoscopic splenectomy to measure changes in kidney function before and after surgery, identify risk factors for kidney damage and whether LSD can improve kidney function in the long term, and help improve care to protect kidney function in cirrhotic patients .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)

Splenomegaly and hypersplenism

History of portal hypertension bleeding (esophageal and gastric variceal bleeding )

Age 18-80 years, male or female

Disqualifiers

Child-Pugh Class C liver cirrhosis

Primary renal diseases (glomerulonephritis, polycystic kidney disease, chronic pyelonephritis, etc.)

Previous abdominal surgery precluding safe laparoscopic splenectomy and azygoportal disconnection

Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders

Trial population

Prospective, single-center, observational cohort study with a total duration of 24 months (2 years). Patients with cirrhosis, Splenomegaly and hypersplenism, Portal Hypertension Bleeding scheduled for Laparoscopic Splenectomy and Azygoportal Disconnection will be enrolled and followed for 2 years to assess renal function dynamics.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Serum creatinine (Scr) level

Change in serum creatinine (Scr) level

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
2

Glomerular filtration rate (eGFR)

Change in estimated glomerular filtration rate (eGFR). For females: If serum creatinine (Scr) ≤ 0.7 mg/dL: eGFR = 142 × (Scr/0.7)\^(-0.241) × (0.9938)\^Age; If Scr \> 0.7 mg/dL: eGFR = 142 × (Scr/0.7)\^(-1.200) × (0.9938)\^Age. For males: If Scr ≤ 0.9 mg/dL: eGFR = 142 × (Scr/0.9)\^(-0.302) × (0.9938)\^Age; If Scr \> 0.9 mg/dL: eGFR = 142 × (Scr/0.9)\^(-1.200) × (0.9938)\^Age. Note: Results are in mL/min/1.73 m². Age is in years.

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
3

BUN and UA level

Changes in BUN and UA level

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
4

Urine albumin-to-creatinine ratio (UACR)

Changes in urine albumin-to-creatinine ratio \[UACR (mg/g) = Urine albumin concentration (mg/L) ÷ Urine creatinine concentration (g/L)\]

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Secondary outcomes

1

Intraoperative variables

operation time, intraoperative blood loss, fluid infusion

Time frame
During the procedure of operation
2

Postoperative complications

postoperative complications (bleeding, infection, hepatic encephalopathy, ascites)

Time frame
at preoperative baseline, postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12, month 18, month 24
3

Child-Pugh grade

Changes in Child-Pugh grade The Child-Pugh score is calculated based on five parameters, each assigned 1, 2, or 3 points. 1. Total bilirubin * Less than 2 mg/dL: 1 point * 2-3 mg/dL: 2 points * Greater than 3 mg/dL: 3 points 2. Serum albumin * Greater than 3.5 g/dL: 1 point * 2.8-3.5 g/dL: 2 points * Less than 2.8 g/dL: 3 points 3. Prothrombin time prolongation or INR * Prolongation less than 4 seconds (INR \< 1.7): 1 point * Prolongation 4-6 seconds (INR 1.7-2.3): 2 points * Prolongation greater than 6 seconds (INR \> 2.3): 3 points 4. Ascites * None: 1 point * Mild or controlled with diuretics: 2 points * Moderate to severe or refractory: 3 points 5. Hepatic encephalopathy * None: 1 point * Grade I-II: 2 points * Grade III-IV: 3 points Total score and corresponding grade * 5-6 points: Child-Pugh class A * 7-9 points: Child-Pugh class B * 10-15 points: Child-Pugh class C

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
4

Albumin and bilirubin level

Changes in albumin and bilirubin level

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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