Effect of Urine-guided Hydration on Acute Kidney Injury After CRS-HIPEC

Status Recruiting

Clinical Trial Summary

Acute renal injury (AKI) is a common complication after cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC), and is associated with worse outcomes. Available evidences show that maintaining intraoperative urine output ≥ 200 ml/h by fluid and furosemide administration may reduce the incidence of AKI in patients undergoing cardiopulmonary bypass. The investigators hypothesize that, for patients undergoing CRS-HIPEC, intraoperative urine-volume guided hydration may also reduce the incidence of postoperative AKI.

Clinical Trial Description

Acute renal injury (AKI) is a common complication after cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC), and is associated with worse outcomes. Studies showed that less intraoperative urine volume was associated with AKI. In studies of contrast-associated AKI, intraoperative and 4-h postoperative hydration and forced diuresis to achieve urine output ≥ 300 ml/h reduces the incidence of AKI by 44%. In patients undergoing cardiac surgery under cardiopulmonary bypass, maintaining intraoperative and 6-h postoperative urine output ≥200 ml/h by fluid and furosemide administration reduces the incidence of AKI by 52%. For patients with rhabdomyolysis, it is recommended to maintain urine output at approximately 3 ml/kg/h (200 ml/h) with volume supplementation. We suppose that forced diuresis with simultaneous hydration (balancing urine output with intravenous fluid infusion) may reduce AKI after CRS-HIPEC. The purpose of this randomised controlled trial is to investigate whether maintaining urine output at 200 ml/h (3 ml/kg/h) or higher by forced diuresis with simultaneous hydration can reduce the incidence of AKI after CRS-HIPEC. ;

Study Design

Related Conditions & MeSH terms

Acute Kidney Injury
Cytoreductive Surgery
Diuresis
Fever
Hydration
Hyperthermia
Hyperthermic Intraperitoneal Chemotherapy
Postoperative Complications
Wounds and Injuries

Clinical Trial Details

NCT number	NCT05939193
Study type	Interventional
Source	Peking University First Hospital
Contact	Dong-Xin Wang, MD, PhD
Phone	010-83572784
Email	wangdongxin@hotmail.com
Status	Recruiting
Phase	N/A
Start date	July 24, 2023
Completion date	January 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05538351` - A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
Recruiting	`NCT06027788` - CTSN Embolic Protection Trial	N/A
Completed	`NCT03938038` - Guidance of Ultrasound in Intensive Care to Direct Euvolemia	N/A
Recruiting	`NCT05805709` - A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial	N/A
Recruiting	`NCT05318196` - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Recruiting	`NCT05897840` - Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients	N/A
Recruiting	`NCT04986137` - Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis
Terminated	`NCT04293744` - Acute Kidney Injury After Cardiac Surgery	N/A
Completed	`NCT04095143` - Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
Not yet recruiting	`NCT06026592` - Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Not yet recruiting	`NCT06064305` - Transcriptional and Proteomic Analysis of Acute Kidney Injury
Terminated	`NCT03438877` - Intensive Versus Regular Dosage For PD In AKI.	N/A
Terminated	`NCT03305549` - Recovery After Dialysis-Requiring Acute Kidney Injury	N/A
Completed	`NCT05990660` - Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery	N/A
Completed	`NCT04062994` - A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
Terminated	`NCT02860130` - Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)	Phase 3
Completed	`NCT06000098` - Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
Not yet recruiting	`NCT05548725` - Relation Between Acute Kidney Injury and Mineral Bone Disease
Completed	`NCT02665377` - Prevention of Akute Kidney Injury, Hearttransplant, ANP	Phase 3
Terminated	`NCT03539861` - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.