UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004690 |
|---|---|
| Receipt number | R000005580 |
| Scientific Title | The effect of tramadol on patients with septic shock caused by generalized peritonitis |
| Date of disclosure of the study information | 2010/12/13 |
| Last modified on | 2010/12/08 18:01:24 |
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Basic information
Public title
The effect of tramadol on patients with septic shock caused by generalized peritonitis
Acronym
The effect of tramadol on patients with septic shock caused by generalized peritonitis
Scientific Title
The effect of tramadol on patients with septic shock caused by generalized peritonitis
Scientific Title:Acronym
The effect of tramadol on patients with septic shock caused by generalized peritonitis
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Anesthesiology | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effect of perioperative administration of tramadol to patients with septic shock caused by generalized peritonitis on hemodynamics and dosage of vasopressor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The norepinephrine requirement during and after surgery
Key secondary outcomes
Organ dysfunction score, infusion volume, urinary output, and cardiovascular drugs requirement
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tramadol 2mg/kg is administered intramuscularly after induction of anesthesia. Since then, same dose of tramadol is administered iteratively every five hours until discharge from the intensive care unit or for up to 48 hours after surgery. Hemodynamic responses around tramadol administration, cardiovascular drug requirement, infusion volume, urine output, and organ dysfunction score is recorded.
Interventions/Control_2
Saline 0.04ml/kg is administered intramuscularly after induction of anesthesia. Since then, same dose of tramadol is administered iteratively every five hours until discharge from the intensive care unit or for up to 48 hours after surgery. Hemodynamic responses around saline administration, cardiovascular drug requirement, infusion volume, urine output, and organ dysfunction score is recorded.
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
After obtaining written informed consent from the patients' next of kin, ASA physical status 1 - 3 patients with generalized peritonitis who are scheduled to undergo the surgery are prospectively enrolled in this study.
P1 A normal healthy patient
P2 A patient with mild systemic disease
P3 A patient with severe systemic disease
P4 A patient with severe systemic disease that is a constant threat to life
P5 A moribund patient who is not expected to survive without the operation
P6 A declared brain-dead patient whose organs are being removed for donor purposes
Key exclusion criteria
1) Age of younger than 18 years
2) Pregnancy
3) Allergy to scheduled drugs
4) Previous history of severe kidney and/or liver disease
5) Previous sulfonylurea use
6) Current use of anticonvulsant drugs
7) Inappropriate patients for study judged by the physicians
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Iranami |
Organization
Japanese Red Cross Society Wakayama Medical Center
Division name
Department of Anesthesiology
Zip code
Address
Komatsubara-dori 4-20, Wakayama, Wakayama 640-8558, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Iranami |
Organization
Japanese Red Cross Society Wakayama Medical Center
Division name
Department of Anesthesiology
Zip code
Address
Komatsubara-dori 4-20, Wakayama, Wakayama 640-8558, Japan
TEL
073-422-4171
Homepage URL
Sponsor or person
Institute
Japanese Red Cross Society Wakayama Medical Center
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
日本赤十字社和歌山医療センター
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 08 | Day |
Last modified on
| 2010 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005580
