Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000095763
Ethics application status
Not yet submitted
Date submitted
22/01/2013
Date registered
24/01/2013
Date last updated
24/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Goal Directed Fluid Therapy using an Oesophageal Doppler in Renal Transplant Surgery
Scientific title
Patients at The Royal Melbourne Hospital presenting for renal transplant will be randomized to goal directed fluid therapy using an oesophageal doppler monitor or standard care, the outcome is duration of hospital stay
Secondary ID [1] 281822 0
None
Universal Trial Number (UTN)
U1111-1138-7753
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Transplant 288172 0
Condition category
Condition code
Anaesthesiology 288534 288534 0 0
Anaesthetics
Surgery 288542 288542 0 0
Other surgery
Renal and Urogenital 288543 288543 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients presenting for renal transplant will be randomized to intra-operative standard fluid therapy(SFT) or intra-operative goal directed fluid therapy using the oesophageal doppler monitor(ODM). All patients will be asked for their duration of preoperative fasting, and time since last dialysis. All patients will be pre-warmed with a forced air warming blanket and intravenous access will be obtained. An arterial line will be inserted only if deemed indicated by the treating anaesthetist.

Once monitored with standard monitoring, a general anaesthetic induction will be commenced with propofol, fentanyl and atracurium. Maintenance of anaesthesia will be with desflurane, fentanyl and an atracurium infusion. Routine immunosuppressive and antibiotic therapy will be administered as per institutional specific therapy.

In ODM Group patients a oesophageal doppler monitor will be inserted after intubation of the trachea and in the ODM group goal directed fluid therapy commenced as guided by the ODM. FTc<350 Normal Saline 7 ml/kg initially then subsequently 3 ml/kg will be administered as a fluid challenge, to return FTc to > 350, as per GUIDELINES FOR IMPLEMENTATION OF ENHANCED RECOVERY PROTOCOLS (1) December 2009. FTc >400 and MAP <70 mmHg metaraminol (heart rate >60 bpm) or ephedrine (heart rate <60 bpm) shall be administered. For the SFT group fluid, vasoconstrictor and ephedrine administration shall be at the discretion of the treating anaesthestist. Total doses of vasoconstrictor and inotrope shall be documented for the intraoperative period for both groups.

(1) Shakeeb Khan et al GUIDELINES FOR IMPLEMENTATION OF ENHANCED RECOVERY PROTOCOLS December 2009
Intervention code [1] 286373 0
Diagnosis / Prognosis
Intervention code [2] 286384 0
Treatment: Other
Comparator / control treatment
Standard fluid management in the operating room, that is the routine management of fluid administration as judged by the anesthetist and the surgeon by indirect measurements such as blood pressure and heart rate.
Control group
Active

Outcomes
Primary outcome [1] 288693 0
disharge from hospital
Timepoint [1] 288693 0
post-operative
Secondary outcome [1] 300773 0
need for dialysis within 48 hours
Timepoint [1] 300773 0
48hours post-operatively
Secondary outcome [2] 300774 0
renal function using measurement of plasma creatinine and urea, also a glomerular filtration rate nuclear medical scan
Timepoint [2] 300774 0
post-operatively daily until discharge (standard management of renal transplant patients) the nuclear medicine scan is performed once before discharge after the transplant while the patient is in hospital
Secondary outcome [3] 300775 0
morbidity as judged by the treating physician observing the patient for pulmonary oedema, myocardial failure, myocardial infarction, stroke, sepsis, haemorrhage, or death.
Timepoint [3] 300775 0
post-operatively for 1year

Eligibility
Key inclusion criteria
All patients for renal transplant
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
refusal
severe pharyngo-oesophageal disease
known severe aortic-arch disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent investigator (research nurse) will then seal each allocation in an opaque envelope and ensure sequential numbering. The number on the envelope will become the participants unique study number.


Once a patient has consented to study participation and immediately prior to commencement of anaesthesia the assigned envelope will be opened by the treating anaesthetist who will then conduct fluid management in accordance with the group the patient is allocated to (standard or goal directed).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated (http://www.randomization.com/) random sequence


Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed in the groups to which patients are randomly allocated, ie, intention to treat analysis. All continuous data will be analyzed for normality. Descriptive statistics including a measure of central tendency and dispersion (mean and standard deviation for normally distributed variables, median and interquartile range for skewed data) will be reported for all relevant variables. Number (percentage) will be used as an alternative where appropriate.

Pearson chi square test will be utilised to analyse categorical data and the mean difference for continuous data will be measured by student t-test (normally distributed data) or Wilcoxon Rank sum test (skewed data).

Regression methods (Logistic regression will be used for categorical data and linear regression for continuous data) will be used to explore the relationships between the fluid strategy patients are allocated to and their perioperative course. All of the perioperative factors listed in th outcomes will be considered by fluid strategy allocation. Demographic and health factors which may impact on the duration of hospital stay will also be included in the model (Age, BMI, IHD, CCF, HLA match, diabetes, hypertension, hyperlipidaemia, pre transplant echo; PVD. Donor source (live vs deceased donor), cold ischaemia time, donor renovascular disease and number of arteries). Co-variates from univariate analyses with p values of <0.2 will be included in the multivariate regression analysis. P values <0.05 will be considered statistically significant for all analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2014
Actual
Date of last participant enrolment
Anticipated
8/08/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 458 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 6214 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 286608 0
Hospital
Name [1] 286608 0
Royal Melbourne Hospital
Department of Anaesthesia and Pain Management
Country [1] 286608 0
Australia
Primary sponsor type
Individual
Name
Ruari M Orme
Address
300 Grattan Street, Parkville, Vic, 3050
Country
Australia
Secondary sponsor category [1] 285395 0
None
Name [1] 285395 0
Address [1] 285395 0
Country [1] 285395 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288682 0
Melbourne Health
Ethics committee address [1] 288682 0
300 Grattan Street, Parkville, Vic, 3050
Ethics committee country [1] 288682 0
Australia
Date submitted for ethics approval [1] 288682 0
04/03/2013
Approval date [1] 288682 0
Ethics approval number [1] 288682 0

Summary
Brief summary
Accurate fluid management in the peritransplant period is crucial. In many cases the donor renal allograft will have established acute tubular necrosis due to prolonged cold ischaemic time and will therefore have delayed graft function. A common complication of transplant surgery is over aggressive fluid replacement in a patient who is essentially anuric which may precipitate pulmonary oedema requiring urgent dialysis. On the other hand, inadequate volume replacement in a renal allograft recipient who has immediate graft function can result in hypovolaemia and potentially delayed graft function. The ODM has been used in case series of renal transplantation demonstrating efficacy and safety. This prospective, randomized trial looks at goal directed fluid therapy using the oesophageal doppler monitor versus standard of care fluid therapy in renal transplant patients to determine if there is a reduced length of stay and reduced incidence of delayed graft function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37250 0
Dr Ruari M Orme
Address 37250 0
Anaesthesiologist
Department of Anaesthesiology and Pain Management
Royal Melbourne Hospital
300 Grattan Street, Parkville, Vic, 3050
Country 37250 0
Australia
Phone 37250 0
+61 3 9342 7000
Fax 37250 0
Email 37250 0
[email protected]
Contact person for public queries
Name 37251 0
Dr Ruari M Orme
Address 37251 0
300 Grattan Street, Parkville, Vic, 3050
Country 37251 0
Australia
Phone 37251 0
+61 3 9342 7000
Fax 37251 0
Email 37251 0
[email protected]
Contact person for scientific queries
Name 37252 0
Dr Ruari M Orme
Address 37252 0
Anaesthesiologist, Department of Anaesthesia and Pain Management
300 Grattan Street, Parkville, Vic, 3050
Country 37252 0
Australia
Phone 37252 0
+61 3 9342 7000
Fax 37252 0
Email 37252 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.