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

Primary Purpose

Cytoreductive Surgery, Hyperthermic Intraperitoneal Chemotherapy, Hydration

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Urine-guided hydration
Routine hydration
Forced administration of furosemide
Routine administration of furosemide
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cytoreductive Surgery focused on measuring Cytoreductive Surgery, Hyperthermic Intraperitoneal Chemotherapy, Hydration, Diuresis, Acute Kidney Injury, Postoperative Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years; Diagnosed as pseudomyxoma peritonei, scheduled for cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy under general anesthesia; At least 14 days since the last treatment of chemotherapy, radiotherapy, or immunotherapy; Consent to participate in this study. Exclusion Criteria: Persistent preoperative atrial fibrillation, or new-onset cardiovascular event (acute coronary syndrome, stroke, or congestive heart failure) in the past 3 months; Requirement of vasopressors to maintain blood pressure before surgery; Known furosemide hypersensitivity; Chronic kidney disease stage 5 or requirement of renal replacement therapy; Other conditions that are considered unsuitable for the study participation.

Sites / Locations

  • Aerospace Center Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Urine-guided hydration

Routine hydration

Arm Description

The target is to maintain urine output at 200 ml/h (3 ml/kg/h) or higher by intravenous injection/infusion of furosemide throughout surgery. That is, a loading dose of 20 mg is injected at the beginning of surgery; if the urine output does not reach the target value, furosemide will be continuously infused at 10 mg/h until the end of the surgery as needed, with a maximum cumulative dose not exceeding 250 mg. Intravenous hydration is performed to balance urine output and to maintain the SVV≤10%.

The target is to maintain urine output at 0.5 ml/kg/h or higher as per current medical practice. That is, furosemide is only administered when clinically necessary or at the discretion of attending anesthesiologists. Intravenous hydration is performed to maintain the SVV≤10%.

Outcomes

Primary Outcome Measures

Incidence of acute kidney injury (AKI) within 7 days after surgery
Acute kidney injury (AKI) is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria.

Secondary Outcome Measures

Classification of AKI within 7 days after surgery
AKI is classified according to the KDIGO criteria.
Intensive care unit (ICU) admission after surgery
ICU admission after surgery
Length of ICU stay after surgery
Length of ICU stay after surgery
Duration of mechanical ventilation after surgery
Duration of mechanical ventilation after surgery
Length of hospital stay after surgery
Length of hospital stay after surgery
Incidence of other organ injuries within 7 days after surgery
Including delirium (assessed with the Confusion Assessment Method [3D-CAM] for patients without mechanical ventilation and CAM-ICU for patients with mechanical ventilation]) within 5 days after surgery, myocardial injury and other organ injuries other than AKI.
All-cause 30-day mortality
All-cause 30-day mortality
Incidence of postoperative major complications
Postoperative major complications were defined as new-onset conditions that were harmful for patients' recovery and required therapeutic intervention, i.e., grade 2 or higher on Clavien-Dindo classification.

Full Information

First Posted
July 2, 2023
Last Updated
July 11, 2023
Sponsor
Peking University First Hospital
Collaborators
Aerospace Center Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05939193
Brief Title
Effect of Urine-guided Hydration on Acute Kidney Injury After CRS-HIPEC
Official Title
Effect of Urine-guided Intraoperative Hydration on the Incidence of Postoperative Acute Kidney Injury and Long-term Outcomes in Patients With Pseudomyxoma Peritonei Receiving CRS-HIPEC: a Prospective, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
Collaborators
Aerospace Center Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytoreductive Surgery, Hyperthermic Intraperitoneal Chemotherapy, Hydration, Diuresis, Acute Kidney Injury, Postoperative Complications
Keywords
Cytoreductive Surgery, Hyperthermic Intraperitoneal Chemotherapy, Hydration, Diuresis, Acute Kidney Injury, Postoperative Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Urine-guided hydration
Arm Type
Experimental
Arm Description
The target is to maintain urine output at 200 ml/h (3 ml/kg/h) or higher by intravenous injection/infusion of furosemide throughout surgery. That is, a loading dose of 20 mg is injected at the beginning of surgery; if the urine output does not reach the target value, furosemide will be continuously infused at 10 mg/h until the end of the surgery as needed, with a maximum cumulative dose not exceeding 250 mg. Intravenous hydration is performed to balance urine output and to maintain the SVV≤10%.
Arm Title
Routine hydration
Arm Type
Active Comparator
Arm Description
The target is to maintain urine output at 0.5 ml/kg/h or higher as per current medical practice. That is, furosemide is only administered when clinically necessary or at the discretion of attending anesthesiologists. Intravenous hydration is performed to maintain the SVV≤10%.
Intervention Type
Procedure
Intervention Name(s)
Urine-guided hydration
Other Intervention Name(s)
Forced administration of furosemide
Intervention Description
The target is to maintain urine output at 200 ml/h (3 ml/kg/h) or higher by intravenous injection/infusion of furosemide throughout surgery. That is, a loading dose of 20 mg is injected at the beginning of surgery; if urine output does not reach the target value, furosemide will be continuously infused at 10 mg/h until the end of surgery, with a cumulative dose not exceeding 250 mg. Intravenous rehydration is performed to balance urine output and to maintain the SVV ≤10%.
Intervention Type
Procedure
Intervention Name(s)
Routine hydration
Other Intervention Name(s)
Routine administration of furosemide
Intervention Description
The target is to maintain urine output at 0.5 ml/kg/h or higher according to routine practice. That is, furosemide is only administered when clinically necessary or at discretion of responsible anesthesiologists; intravenous rehydration is performed to maintain the SVV ≤10%.
Intervention Type
Drug
Intervention Name(s)
Forced administration of furosemide
Intervention Description
Forced administration of furosemide
Intervention Type
Drug
Intervention Name(s)
Routine administration of furosemide
Intervention Description
Routine administration of furosemide
Primary Outcome Measure Information:
Title
Incidence of acute kidney injury (AKI) within 7 days after surgery
Description
Acute kidney injury (AKI) is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Time Frame
Up to 7 days after surgery
Secondary Outcome Measure Information:
Title
Classification of AKI within 7 days after surgery
Description
AKI is classified according to the KDIGO criteria.
Time Frame
Up to 7 days after surgery
Title
Intensive care unit (ICU) admission after surgery
Description
ICU admission after surgery
Time Frame
Up to 30 days after surgery
Title
Length of ICU stay after surgery
Description
Length of ICU stay after surgery
Time Frame
Up to 30 days after surgery
Title
Duration of mechanical ventilation after surgery
Description
Duration of mechanical ventilation after surgery
Time Frame
Up to 30 days after surgery
Title
Length of hospital stay after surgery
Description
Length of hospital stay after surgery
Time Frame
Up to 30 days after surgery
Title
Incidence of other organ injuries within 7 days after surgery
Description
Including delirium (assessed with the Confusion Assessment Method [3D-CAM] for patients without mechanical ventilation and CAM-ICU for patients with mechanical ventilation]) within 5 days after surgery, myocardial injury and other organ injuries other than AKI.
Time Frame
Up to 7 days after surgery
Title
All-cause 30-day mortality
Description
All-cause 30-day mortality
Time Frame
Up to 30 days after surgery
Title
Incidence of postoperative major complications
Description
Postoperative major complications were defined as new-onset conditions that were harmful for patients' recovery and required therapeutic intervention, i.e., grade 2 or higher on Clavien-Dindo classification.
Time Frame
Up to 30 days after surgery
Other Pre-specified Outcome Measures:
Title
Incidence of deterioration in renal function
Description
Defined as ≥1 grade decrease in glomerular filtration rate compared with preoperative value.
Time Frame
Up to 6 months after surgery
Title
Recurrence/progress-free survival
Description
Defined as time from surgery to pseudomyxoma peritonei recurrence/progress/metastasis or all-cause death, whichever occurs first.
Time Frame
Up to 6 months after surgery
Title
Event-free survival
Description
Defined as time from surgery to pseudomyxoma peritonei recurrence/progress/metastasis, unplanned re-hospitalization for non-pseudomyxoma peritonei diseases, or all-cause death, whichever occurs first.
Time Frame
Up to 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years; Diagnosed as pseudomyxoma peritonei, scheduled for cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy under general anesthesia; At least 14 days since the last treatment of chemotherapy, radiotherapy, or immunotherapy; Consent to participate in this study. Exclusion Criteria: Persistent preoperative atrial fibrillation, or new-onset cardiovascular event (acute coronary syndrome, stroke, or congestive heart failure) in the past 3 months; Requirement of vasopressors to maintain blood pressure before surgery; Known furosemide hypersensitivity; Chronic kidney disease stage 5 or requirement of renal replacement therapy; Other conditions that are considered unsuitable for the study participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Xin Wang, MD, PhD
Phone
010-83572784
Email
wangdongxin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shun-Cai Gao, MD
Phone
8617610740223
Email
aschgaosc@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Organizational Affiliation
Peking University First Hospital, Beijing, CHINA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aerospace Center Hospital
City
Beijing
ZIP/Postal Code
100049
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shun-Cai Gao, MD
Phone
8617610740223
Email
aschgaosc@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34260006
Citation
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Results Reference
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30674567
Citation
Angeles MA, Quenet F, Vieille P, Gladieff L, Ruiz J, Picard M, Migliorelli F, Chaltiel L, Martinez-Gomez C, Martinez A, Ferron G. Predictive risk factors of acute kidney injury after cytoreductive surgery and cisplatin-based hyperthermic intra-peritoneal chemotherapy for ovarian peritoneal carcinomatosis. Int J Gynecol Cancer. 2019 Feb;29(2):382-391. doi: 10.1136/ijgc-2018-000099. Epub 2019 Jan 23.
Results Reference
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PubMed Identifier
25155314
Citation
Hakeam HA, Breakiet M, Azzam A, Nadeem A, Amin T. The incidence of cisplatin nephrotoxicity post hyperthermic intraperitoneal chemotherapy (HIPEC) and cytoreductive surgery. Ren Fail. 2014 Nov;36(10):1486-91. doi: 10.3109/0886022X.2014.949758. Epub 2014 Aug 26.
Results Reference
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PubMed Identifier
31602673
Citation
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Results Reference
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PubMed Identifier
31879421
Citation
Solanki SL, Mukherjee S, Agarwal V, Thota RS, Balakrishnan K, Shah SB, Desai N, Garg R, Ambulkar RP, Bhorkar NM, Patro V, Sinukumar S, Venketeswaran MV, Joshi MP, Chikkalingegowda RH, Gottumukkala V, Owusu-Agyemang P, Saklani AP, Mehta SS, Seshadri RA, Bell JC, Bhatnagar S, Divatia JV. Society of Onco-Anaesthesia and Perioperative Care consensus guidelines for perioperative management of patients for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). Indian J Anaesth. 2019 Dec;63(12):972-987. doi: 10.4103/ija.IJA_765_19. Epub 2019 Dec 11.
Results Reference
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Citation
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Results Reference
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Citation
Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Reduction in acute kidney injury post cardiac surgery using balanced forced diuresis: a randomized, controlled trial. Eur J Cardiothorac Surg. 2021 Apr 13;59(3):562-569. doi: 10.1093/ejcts/ezaa395.
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Results Reference
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Effect of Urine-guided Hydration on Acute Kidney Injury After CRS-HIPEC

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