UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031160 |
|---|---|
| Receipt number | R000035549 |
| Scientific Title | Effect of the choice of postoperative maintenance infusion on patient prognosis:an open-label, randomized controlled trial. |
| Date of disclosure of the study information | 2018/02/05 |
| Last modified on | 2021/02/07 09:53:15 |
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Basic information
Public title
Effect of the choice of postoperative maintenance infusion on patient prognosis:an open-label, randomized controlled trial.
Acronym
Effect of postoperative maintenance transfusion on patient prognosis.
Scientific Title
Effect of the choice of postoperative maintenance infusion on patient prognosis:an open-label, randomized controlled trial.
Scientific Title:Acronym
Effect of postoperative maintenance transfusion on patient prognosis.
Region
| Japan |
Condition
Condition
postoperative critically ill patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of choice of maintenance infusion on the incidence of hyponatremia 3 days after surgery.
Basic objectives2
Others
Basic objectives -Others
To assess the effects of choice of maintenance infusion on the following.
1) Incidence of hypernatremia 3 days after surgery.
2) Postoperative change in serum Na concentration, electrolytes other than Na, postoperative transition of blood glucose level and serum osmotic pressure.
3) Serum vasopressin concentration, cortisol concentration, serum BNP concentration, urinary electrolyte concentration, serum S100 beta concentration and serum neuron-specific enolase concentration immediately after surgery and on the 1st to 3rd postoperative days.
4) Incidence of postoperative delirium during stay in the ICU.
5) Postoperative organ injury during stay in the ICU and ICU-free survival days.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of hyponatremia (serum Na concentration less than 136 mmol/L) 3 days after surgery.
Key secondary outcomes
1) Changes in serum vasopressin concentration, cortisol concentration, serum BNP concentration and urinary electrolyte concentration immediately after surgery and on the 1st to 3rd postoperative days.
2) Changes in serum S100 beta concentration and serum neuron-specific enolase concentration immediately after surgery and on the 1st to 3rd postoperative days.
3) Incidence of postoperative delirium during stay in the ICU.
4) Incidence and severity of postoperative organ injury during stay in the ICU
5) ICU-free survival days for 28 days after surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Saline + 5% glucose (same dose) will be administered at a rate of (body weight + 40) ml / h.
Intervention period:
From: Postoperative admission to the intensive care unit
To: Postoperative day 3 (6:00 AM)
Interventions/Control_2
Ringer's solution will be administered at a rate of (body weight + 40) ml / h.
Intervention period:
From: Postoperative admission to the intensive care unit
To: Postoperative day 3 (6:00 AM)
Interventions/Control_3
Maintenance solution will be administered at a rate of (body weight + 40) ml / h.
Intervention period:
From: Postoperative admission to the intensive care unit
To: Postoperative day 3 (6:00 AM)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 20 years or older.
2) Patients who will undergo elective esophageal cancer surgery or elective head and neck cancer surgery.
3) Patients requiring postoperative intensive care for 48 hours or more.
Key exclusion criteria
1) Patients with preoperative eGFR <= 50 ml / min.
2) Patients with preoperative total bilirubin value >= 2 mg / dL.
3) Patients with a history of heart failure
4) Pregnant women and patients who may be pregnant or breast-feeding patients.
5) Patients who are judged to be inappropriate.
Target sample size
225
Research contact person
Name of lead principal investigator
| 1st name | Moritoki |
| Middle name | |
| Last name | Egi |
Organization
Kobe University Hospital
Division name
Department of Anesthesiology
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi
TEL
078-382-6172
moriori@tg8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Moritoki |
| Middle name | |
| Last name | Egi |
Organization
Kobe university graduate school of medicine
Division name
Division of anesthesiology, Department of suegery related,
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi
TEL
078-382-6172
Homepage URL
moriori@tg8.so-net.ne.jp
Sponsor or person
Institute
Kobe university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB committee Kobe University hospital
Address
7-5-2 Kusunokityo Kobe city Hyogo
Tel
078-382-5111
moriori@tg8.so-net.ne.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 05 | Day |
Last modified on
| 2021 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035549
