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出境医 / 临床实验 / Effects of Anesthetic Techniques on Renal Function
Effects of Anesthetic Techniques on Renal Function
Study Description
Brief Summary:
This study evaluates Different effects of two anesthetic techniques on renal function during the perioperative period of cardiac surgery in children.
| Condition or disease | Intervention/treatment |
|---|---|
| Congenital Heart Disease Acute Kidney Injury | Other: inhalation anesthesia Other: Total intravenous anesthesia |
Detailed Description:
Acute kidney injury is one of the major complications after heart surgery, which increases the mortality of patients. Therefore, early prevention and detection of acute kidney injury is particularly important. In recent years, more and more studies have shown that both sevoflurane, an inhaled anesthetic widely used in clinical practice, and propofol, an intravenous anesthetic, have protective effects on kidneys. The aim of this study was to investigate the perioperative effects of two different anesthetic techniques on renal function for pediatric cardiac surgery.
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 60 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Different Effects of Two Anesthetic Techniques on Renal Function During the Perioperative Period of Cardiac Surgery in Children |
| Actual Study Start Date : | January 1, 2019 |
| Actual Primary Completion Date : | September 30, 2019 |
| Actual Study Completion Date : | September 30, 2019 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Group A: Sevoflurane, sufentanil and rocuronium
sevoflurane (1-3%)and sufentanil (0.5-2 mcg/kg/h) and rocuronium (0.3～0.6mg/kg/h) used intraoperatively as required
|
Other: inhalation anesthesia
sevoflurane was used to maintain anesthesia
|
|
Group B: Propofol, sufentanil and rocuronium
propofol (4-12 mg/kg/h) and sufentanil (0.5-2 mcg/kg/h/) and rocuronium (0.3～0.6mg/kg/h) used intraoperatively as required
|
Other: Total intravenous anesthesia
propofol was used to maintain anesthesia
|
Outcome Measures
Primary Outcome Measures :
- renal blood flow [ Time Frame: 2 days ]Changes of blood flow information of renal artery was obtained before anesthesia induction, after anesthesia, at the end of operation and 24 hours after surgery, unit(cm/s)
Secondary Outcome Measures :
- neutrophil gelatinase-associated lipocalin , NGAL [ Time Frame: 2 days ]Changes of blood NGAL were obtained before and 2 hours after surgery, unit(ng/ml)
- creatinine [ Time Frame: 3 and 4 days ]Changes of creatinine before and 3 days after acquisition, unit (mmol/L)
- Mean arterial pressure [ Time Frame: 2 days ]Mean arterial pressure synchronized with renal blood flow was recorded, unit (mmHg)
- cardiopulmonary bypass (CPB) time [ Time Frame: 24 hours ]Cardiopulmonary bypass time was recorded, unit(minutes)
Eligibility Criteria
| Ages Eligible for Study: | up to 3 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
After approved by the ethics committee, sixty patients who met the inclusion criteria of this study with their parents' informed consent in Children's Hospital of Fudan University.
Criteria
Inclusion Criteria:
- children with congenital heart disease
- <3 years of age
Exclusion Criteria:
- preoperative renal insufficiency;
- renal malformation, kidney absence
Contacts and Locations
Locations
| China, Shanghai | |
| Children's Hospital of Fudan University | |
| Shanghai, Shanghai, China | |
Sponsors and Collaborators
Huiying Shao
Investigators
| Study Director: | mazhong zhang, MD | Shanghai Children's Medical Center |
| Tracking Information | ||||
|---|---|---|---|---|
| First Submitted Date | July 2, 2019 | |||
| First Posted Date | July 24, 2019 | |||
| Last Update Posted Date | October 21, 2019 | |||
| Actual Study Start Date | January 1, 2019 | |||
| Actual Primary Completion Date | September 30, 2019 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures |
renal blood flow [ Time Frame: 2 days ] Changes of blood flow information of renal artery was obtained before anesthesia induction, after anesthesia, at the end of operation and 24 hours after surgery, unit(cm/s)
|
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| Original Primary Outcome Measures | Same as current | |||
| Change History | ||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | |||
| Current Other Pre-specified Outcome Measures | Not Provided | |||
| Original Other Pre-specified Outcome Measures | Not Provided | |||
| Descriptive Information | ||||
| Brief Title | Effects of Anesthetic Techniques on Renal Function | |||
| Official Title | Different Effects of Two Anesthetic Techniques on Renal Function During the Perioperative Period of Cardiac Surgery in Children | |||
| Brief Summary | This study evaluates Different effects of two anesthetic techniques on renal function during the perioperative period of cardiac surgery in children. | |||
| Detailed Description | Acute kidney injury is one of the major complications after heart surgery, which increases the mortality of patients. Therefore, early prevention and detection of acute kidney injury is particularly important. In recent years, more and more studies have shown that both sevoflurane, an inhaled anesthetic widely used in clinical practice, and propofol, an intravenous anesthetic, have protective effects on kidneys. The aim of this study was to investigate the perioperative effects of two different anesthetic techniques on renal function for pediatric cardiac surgery. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | After approved by the ethics committee, sixty patients who met the inclusion criteria of this study with their parents' informed consent in Children's Hospital of Fudan University. | |||
| Condition |
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| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment |
60 | |||
| Original Estimated Enrollment | Same as current | |||
| Actual Study Completion Date | September 30, 2019 | |||
| Actual Primary Completion Date | September 30, 2019 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | up to 3 Years (Child) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | China | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT04030481 | |||
| Other Study ID Numbers | DEOTATORFDTPPOCSIC | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Huiying Shao, Children's Hospital of Fudan University | |||
| Study Sponsor | Huiying Shao | |||
| Collaborators | Not Provided | |||
| Investigators |
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| PRS Account | Children's Hospital of Fudan University | |||
| Verification Date | October 2019 | |||
