Effects of Intraoperative Fluid Therapy on Acute Kidney Injury After Thoracoscopic Lobectomy

NCT04302467 | Completed

• 1 other identifier: XJTU1AF-CRF-2019-012
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Acute kidney injury (AKI) often occurs after thoracoscopic lobectomy in high risk patients. Insufficient intraoperative infusion is risk factor of AKI. Goal-directed fluid therapy (GDFT) is individualized fluid infusion strategy, the infusion rate and type is adjusted according to the individual's fluid response. GDFT during operation can reduce the incidence of AKI after major surgery. Enhanced recovery after surgery (ERAS) integrates a range of perioperative interventions to decrease postoperative complications after surgery. In ERAS protocol of lobectomy, restrictive fluid therapy during operation is recommended. In this study, the investigators will compare the effects of GDFT and restrictive fluid therapy during operation combined with ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high risk patients. Methods/design: This is prospective single-center single-blind randomized controlled trial. 276 patients scheduled to undergo thoracoscopic lobectomy under general anesthesia combined with paravertebral block are randomly divided into GDFT group and restrictive fluid therapy group at a 1:1 ratio. The primary outcome is the incidence of AKI after operation. The secondary outcomes are (1) the incidence of renal replacement therapy, (2) length of intensive care unit (ICU) stay after operation, (3) length of hospital stay after operation , (4) incidence of other complications including: infection, acute lung injury (ALI), pneumonia, arrhythmia, heart failure, myocardial injury after noncardiac surgery (MINS), cardiac infarction. Discussion: This is the first study to compare GDFT and restrictive fluid therapy during operation combined with ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high risk patients. The investigators expected that the two methods have the same effect on the incidence of AKI, but restrictive fluid therapy is simpler to applied than GDFT.

Conditions

Acute Kidney Injury

Keywords

Acute kidney injury; Goal-directed fluid therapy; Enhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

• number of participants with acute kidney injury

  50% relative or 0.3 mg/dl (26.5 μmol/L) absolute increase in creatinine over the preoperative value during the first two postoperative days.

  48 hours after operation

Secondary Outcomes (10)

• number of participants in need of renal replacement therapy

  30 days after operation

• length of ICU stay after operation

  30 days after operation

• length of hospital stay after operation

  30 days after operation

• number of participants with infection

  30 days after operation

• number of participants with acute lung injury

  24 hours after operation

Study Arms (2)

GDFT group

EXPERIMENTAL

Fluid maintenance with 2 ml/kg/h of Ringer's solution of sodium acetate, when SVV\>13%, 4 mL/kg bolus of hydroxyethyl starch will be infused within 5 min. If SVV falls below 13%, the bolus will be suspended. If SVV is still more than 13%, 100 μg of phenylephrine will be administered when CI is more than 2.5 L/min/m2, 1 mg of dopamine will be administered when CI is less than 2.5 L/min/m2. When SVV\<13%, but mean arterial pressure (MAP)\<65 mmHg, 8 μg of norepinephrine will be administered. The hemodynamic status will be repeatedly measured every 10 min.

Procedure: fluid therapy during operation

restrictive fluid therapy group

EXPERIMENTAL

fluid maintenance with 2 ml/kg/h of Ringer's solution of sodium acetate, hydroxyethyl starch will be infused to supply blood loss, the ratio of hydroxyethyl starch to blood loss is 1:1. 0.01-0.1 μg/kg/min of norepinephrine will be administered to maintain MAP\>65 mmHg.

Procedure: fluid therapy during operation

Interventions

fluid therapy during operation PROCEDURE

ERAS protocol of lobectomy will implemented to all the participants during perioperation,two groups of participants will be given different intraoperative fluid therapy strategy.

Also known as: Implement ERAS protocol of lobectomy during perioperation

GDFT group; restrictive fluid therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>70 years old
• Forced expiratory volume in 1 second (FEV1)\<60%
• Carbon monoxide lung diffusion capacity (DLCO)\<60%
• History of coronary artery disease

You may not qualify if:

• Patients refused
• Creatinine\>176 μmol/L, and/or BUN\>7.1 mmol/L
• NT-proBNP\>300 ng/L
• Systemic or local infection
• Albumin\<30 g/L, and/or Hemoglobin\<100 g/L
• Allergy to hydroxyethyl starch

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (2)

• Ma H, Li X, Wang Z, Qiao Q, Gao Y, Yuan H, Guan B, Guan Z. The effect of intraoperative goal-directed fluid therapy combined with enhanced recovery after surgery program on postoperative complications in elderly patients undergoing thoracoscopic pulmonary resection: a prospective randomized controlled study. Perioper Med (Lond). 2023 Jul 10;12(1):33. doi: 10.1186/s13741-023-00327-x.

  PMID: 37430359 DERIVED

• Guan Z, Gao Y, Qiao Q, Wang Q, Liu J. Effects of intraoperative goal-directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high-risk patients: study protocol for a prospective randomized controlled trial. Trials. 2021 Jan 7;22(1):36. doi: 10.1186/s13063-020-04983-y.

  PMID: 33413593 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Zheng Guan, MD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocations will be blinded to all participants but the anesthesiologists. If serious adverse events occur, the patients will be removed from the trial, the blinding will be removed, the events will be reported to the institutional review board.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated to one of the two groups: (1) GDFT group and (2) restrictive fluid therapy group. They will be allocated in a 1:1 ratio using random numbers generated by Microsoft Excel.

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 10, 2020
• Study Start: May 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: August 31, 2022
• Last Updated: November 1, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)