HyponatremiaNCT03840629
Fluid Tonicity and Hyponatraemia Post Surgery
An observational study of Hyponatremia and Surgery, run by National University Hospital, Singapore.
Trial summary
Retrospective audit of adult patients who underwent major surgery in our institution, and biochemical outcomes including hyponatremia, in relation to the maintenance fluid tonicity administered peri-operatively. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hyponatremia, Surgery, Fluid and Electrolyte Imbalance
- What is being tested?
- No study intervention.
- How many people
- 659 participants
- Where
- No sites listed yet
- Study dates
- 13 Nov 2014to 12 Nov 2015
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult surgical patients
Who may be able to join
- exclusive administration of either fluid types.
Who cannot join
- Patients who received saline boluses
About this study
Official title: Impact of Maintenance Fluid Tonicity on Natraemia in Post-surgical Adult Patients
Retrospective audit of adult patients who underwent major surgery in our institution, and biochemical outcomes including hyponatremia, in relation to the maintenance fluid tonicity administered peri-operatively.
Read the detailed description
Hyponatraemia is a common electrolyte abnormality which is hospital-acquired in two-thirds of cases, and can lead to obtundation, seizures, encephalopathy and death. In children, the use of hypotonic maintenance fluids had been routine until recent evidence showing that they were associated with an increased incidence of hyponatraemia, with consequent increases in morbidity and mortality. Comparative data in adults is limited.
In our institution, the National University Hospital, Singapore, a hypotonic solution of 0.33% saline pre-mixed with 10mM KCl per 500ml has been in common use for years for surgical patients. This is largely based on calculations of daily requirements (1-1.5mM/kg of sodium and 1mM/kg of potassium) and reduction of risk associated with measuring out KCl and injecting it into drip bags. However, this solution is hypotonic (134mM) compared to plasma, and its administration could theoretically increase the risk of subsequent hyponatraemia.
In this single-centre retrospective observational study, we aim to compare the biochemical outcomes of hospitalised surgical adult patients who have been given hypotonic (0.33% saline) compared to isotonic or near-isotonic solutions (0.9% saline or Hartmann's solution) between March and September 2013. We hypothesize that hypotonic solutions are more likely to cause a post-operative hyponatraemia and subsequent complications compared to their isotonic counterparts. The complications of hyponatraemia are defined in this study as new ICU admissions and increased mortality.
Inappropriate fluid prescription is a contributor to iatrogenic morbidity and mortality. Our study aims to evaluate the safety of a hypotonic solution in standard use. The results will help guide fluid choice, especially in the absence of current evidence-based national guidelines. As it is a retrospective study, there are no risks involved.
This is a single-centre retrospective observational study based on electronic medical records collected between the months of March 2012 and September 2013. Patients will be divided into two groups - one which received hypotonic 0.33% saline, and another which received isotonic or near-isotonic solutions (0.9% saline or Hartmann's solution). Serum sodium, chloride, bicarbonate and creatinine measured pre-operatively will be compared to post-operative values obtained 24-48 hours later.
- All medication (including fluids) administered during an inpatient stay at NUH are logged and stored electronically via the inpatient medication record system. Following a patient's discharge, this information is stored on the hospital's servers and accessible by pharmacy. By searching for a certain medication, e.g. "normal saline", a list of all patients given that medication during a certain time period can be generated, along with associated data such as when the medication was commenced and stopped.
- From this list of patients, their IDs can be used to extract surgical data from electronic records which are automatically created every time an operative report (i.e. every time a surgical procedure is completed) is issued. Variables obtained from this database include the surgical procedure name, code, performing department, etc.
- For biochemical data, the hospital's electronic medical records can be searched by patient IDs. Details such as documented past medical history and laboratory indices are available. By comparing dates of surgery to dates of renal panels taken for a specific patient, pre-operative and post-operative variables can be identified and extracted.
- Conditions
- Hyponatremia, Surgery, Fluid and Electrolyte Imbalance
- Being tested
- No study intervention.
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No study intervention.Other
| Study group | Role | What they receive |
|---|---|---|
| Hypotonic fluid maintenance | exclusive administration of 0.33% saline mixed with potassium and dextrose 5% Receives: Other: No study intervention. | |
| Isotonic fluid maintenance | exclusive administration of 0.9% saline Receives: Other: No study intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyponatraemia
Hyponatraemia post surgery
Measured: 48 to 72 hrs post surgery
Secondary outcomes (2)
Hypokalemia
Hypokalemia post surgery
Measured: 48 to 72 hrs post surgery
Acute kidney injury
AKI post surgery
Measured: 48 to 72 hrs post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start13 Nov 2014
- Primary completion12 Jun 2015
- Study completion12 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840629
- Sponsor's protocol ID
- DSRB2013/01040
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Request to be made to corresponding author please
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Maintenance Fluid Tonicity on Natraemia in Post-surgical Adult Patients
- ClinicalTrials.gov ID
- NCT03840629
- Acronym / sponsor ID
- DSRB2013/01040
- Conditions
- Hyponatremia, Surgery, Fluid and Electrolyte Imbalance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 13 Nov 2014 (actual)
- Primary completion
- 12 Jun 2015 (actual)
- Study completion
- 12 Nov 2015 (actual)
- First posted
- 15 Feb 2019 (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.
Retrospective audit of adult patients who underwent major surgery in our institution, and biochemical outcomes including hyponatremia, in relation to the maintenance fluid tonicity administered peri-operatively.
Detailed description
Hyponatraemia is a common electrolyte abnormality which is hospital-acquired in two-thirds of cases, and can lead to obtundation, seizures, encephalopathy and death. In children, the use of hypotonic maintenance fluids had been routine until recent evidence showing that they were associated with an increased incidence of hyponatraemia, with consequent increases in morbidity and mortality. Comparative data in adults is limited.
In our institution, the National University Hospital, Singapore, a hypotonic solution of 0.33% saline pre-mixed with 10mM KCl per 500ml has been in common use for years for surgical patients. This is largely based on calculations of daily requirements (1-1.5mM/kg of sodium and 1mM/kg of potassium) and reduction of risk associated with measuring out KCl and injecting it into drip bags. However, this solution is hypotonic (134mM) compared to plasma, and its administration could theoretically increase the risk of subsequent hyponatraemia.
In this single-centre retrospective observational study, we aim to compare the biochemical outcomes of hospitalised surgical adult patients who have been given hypotonic (0.33% saline) compared to isotonic or near-isotonic solutions (0.9% saline or Hartmann's solution) between March and September 2013. We hypothesize that hypotonic solutions are more likely to cause a post-operative hyponatraemia and subsequent complications compared to their isotonic counterparts. The complications of hyponatraemia are defined in this study as new ICU admissions and increased mortality.
Inappropriate fluid prescription is a contributor to iatrogenic morbidity and mortality. Our study aims to evaluate the safety of a hypotonic solution in standard use. The results will help guide fluid choice, especially in the absence of current evidence-based national guidelines. As it is a retrospective study, there are no risks involved.
This is a single-centre retrospective observational study based on electronic medical records collected between the months of March 2012 and September 2013. Patients will be divided into two groups - one which received hypotonic 0.33% saline, and another which received isotonic or near-isotonic solutions (0.9% saline or Hartmann's solution). Serum sodium, chloride, bicarbonate and creatinine measured pre-operatively will be compared to post-operative values obtained 24-48 hours later.
- All medication (including fluids) administered during an inpatient stay at NUH are logged and stored electronically via the inpatient medication record system. Following a patient's discharge, this information is stored on the hospital's servers and accessible by pharmacy. By searching for a certain medication, e.g. "normal saline", a list of all patients given that medication during a certain time period can be generated, along with associated data such as when the medication was commenced and stopped.
- From this list of patients, their IDs can be used to extract surgical data from electronic records which are automatically created every time an operative report (i.e. every time a surgical procedure is completed) is issued. Variables obtained from this database include the surgical procedure name, code, performing department, etc.
- For biochemical data, the hospital's electronic medical records can be searched by patient IDs. Details such as documented past medical history and laboratory indices are available. By comparing dates of surgery to dates of renal panels taken for a specific patient, pre-operative and post-operative variables can be identified and extracted.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypotonic fluid maintenance | – | Other: No study intervention.exclusive administration of 0.33% saline mixed with potassium and dextrose 5% |
| Isotonic fluid maintenance | – | Other: No study intervention.exclusive administration of 0.9% saline |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult surgical patients
Key inclusion criteria (1 listed)
- exclusive administration of either fluid types.
Key exclusion criteria (1 listed)
- Patients who received saline boluses
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 |
|---|---|---|
| No study intervention. | Other | Hypotonic fluid maintenance, Isotonic fluid maintenance |
Primary outcome
Hyponatraemia
Time frame: 48 to 72 hrs post surgery
Hyponatraemia post surgery
2 secondary outcomes
Hypokalemia
Time frame: 48 to 72 hrs post surgery
Acute kidney injury
Time frame: 48 to 72 hrs post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Undecided. Request to be made to corresponding author please
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia and Surgery, run by National University Hospital, Singapore.
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: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyponatraemia (time frame: 48 to 72 hrs post 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 Feb 2019.