Acid-Base Balance DisorderPhase 4NCT03115060
Comparison of Plasmalyte A, Normal Saline and Ringer Lactate as Intraoperative Fluid During Renal Transplantation
A Phase 4 study testing intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE in people with Acid-Base Balance Disorder, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Fluid management being an important component of surgery becomes more challenging for an anesthesiologist in case of renal transplant. Ischemia-reperfusion injury is an inevitable consequence of kidney transplantation, leading to metabolic acidosis .Normal saline (NS; 0.9% NaCl) is administered during kidney… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Acid-Base Balance Disorder
- What is being tested?
- intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2015to Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients undergoing elective living donor renal transplant
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIMER
Chandigarh, 160012
vikas saini, 7087008119, drvsaini@gmail.com
About this study
Official title: Comparison of Plasmalyte A, Normal Saline and Ringer Lactate as Intraoperative Fluids in Patients Undergoing Renal Transplantation.
Fluid management being an important component of surgery becomes more challenging for an anesthesiologist in case of renal transplant. Ischemia-reperfusion injury is an inevitable consequence of kidney transplantation, leading to metabolic acidosis .Normal saline (NS; 0.9% NaCl) is administered during kidney transplantation to avoid the risk of hyperkalemia associated with potassium-containing fluids. Plasmalyte is another fluid which can be used and probably will lead to better metabolic profile in these group of patients.The primary objective of this study will be to compare the effects of using normal saline (NS), Ringer lactate and Plasmalyte as intravenous fluids on acid-base balance and electrolytes during living donor kidney transplantation. Secondary outcomes assessed will be the effect on renal function.
- Conditions
- Acid-Base Balance Disorder
- Being tested
- intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATEDrug
intravenous fluid to be used for maintainance and replacement during renal transplant surgery will be normal saline, ringer lactate or plasmalyte A depending on the arm of intervention
| Study group | Role | What they receive |
|---|---|---|
| normal saline | Experimental | Intravenous fluid used in these patients would be normal saline which would be given intravenously during intraoperative and postoperative period Receives: Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE |
| ringer lactate | Experimental | Intravenous fluid used in these patients would be ringer lactate which would be given intravenously during intraoperative and postoperative period Receives: Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE |
| plasmalyte A | Experimental | Intravenous fluid used in this arm in patients would be plasmalyte A which would be given intravenously during intraoperative and postoperative period Receives: Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
acid base balance, 4 readings intraoperaively to be taken using arterial blood sample of the patient
pH, pCO2, pO2, HCO3,Base deficit, Na, K are the values normally measured in acid base analysis
Measured: during the surgery
Secondary outcomes (2)
serum creatinine on day 1, 2 and 7 of surgery
This is a function of kidney measure and will tell about the success of Renal Transplant
Measured: day 1, 2 and 7
intraoperative hemodynamics in all patients
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start1 Apr 2015
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acid-Base Balance DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Vikas Saini, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115060
- Sponsor's protocol ID
- INT/IEC/2016/937
- Status last verified
- Apr 2017
- First submitted
- 6 Apr 2017
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Plasmalyte A, Normal Saline and Ringer Lactate as Intraoperative Fluids in Patients Undergoing Renal Transplantation.
- ClinicalTrials.gov ID
- NCT03115060
- Acronym / sponsor ID
- INT/IEC/2016/937
- Conditions
- Acid-Base Balance Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fluid management being an important component of surgery becomes more challenging for an anesthesiologist in case of renal transplant. Ischemia-reperfusion injury is an inevitable consequence of kidney transplantation, leading to metabolic acidosis .Normal saline (NS; 0.9% NaCl) is administered during kidney transplantation to avoid the risk of hyperkalemia associated with potassium-containing fluids. Plasmalyte is another fluid which can be used and probably will lead to better metabolic profile in these group of patients.The primary objective of this study will be to compare the effects of using normal saline (NS), Ringer lactate and Plasmalyte as intravenous fluids on acid-base balance and electrolytes during living donor kidney transplantation. Secondary outcomes assessed will be the effect on renal function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal saline | Experimental | Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATEIntravenous fluid used in these patients would be normal saline which would be given intravenously during intraoperative and postoperative period |
| ringer lactate | Experimental | Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATEIntravenous fluid used in these patients would be ringer lactate which would be given intravenously during intraoperative and postoperative period |
| plasmalyte A | Experimental | Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATEIntravenous fluid used in this arm in patients would be plasmalyte A which would be given intravenously during intraoperative and postoperative period |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients undergoing elective living donor renal transplant
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATEintravenous fluid to be used for maintainance and replacement during renal transplant surgery will be normal saline, ringer lactate or plasmalyte A depending on the arm of intervention | Drug | normal saline, plasmalyte A, ringer lactate |
Primary outcome
acid base balance, 4 readings intraoperaively to be taken using arterial blood sample of the patient
Time frame: during the surgery
pH, pCO2, pO2, HCO3,Base deficit, Na, K are the values normally measured in acid base analysis
2 secondary outcomes
serum creatinine on day 1, 2 and 7 of surgery
Time frame: day 1, 2 and 7
intraoperative hemodynamics in all patients
Time frame: intraoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE in people with Acid-Base Balance Disorder, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tanvir samra, MD Anaesthesia (7087008799, drtanvirsamra@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acid base balance, 4 readings intraoperaively to be taken using arterial blood sample of the patient (time frame: during the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.