Surgery Clinical Trial
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.
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.
1. 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.
2. 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.
3. 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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
Enrolling by invitation |
NCT05534490 -
Surgery and Functionality in Older Adults
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Terminated |
NCT04612491 -
Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
|
||
Recruiting |
NCT06397287 -
PROM Project Urology
|
||
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
Completed |
NCT03432429 -
Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
|
||
Completed |
NCT04176822 -
Designing Animated Movie for Preoperative Period
|
N/A | |
Recruiting |
NCT05370404 -
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
|
N/A | |
Not yet recruiting |
NCT05467319 -
Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS
|
Phase 3 | |
Recruiting |
NCT04602429 -
Children's Acute Surgical Abdomen Programme
|
||
Completed |
NCT03124901 -
Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor
|
N/A | |
Completed |
NCT04595695 -
The Effect of Clear Masks in Improving Patient Relationships
|
N/A | |
Recruiting |
NCT06103136 -
Maestro 1.0 Post-Market Registry
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Completed |
NCT04059328 -
Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
|
||
Recruiting |
NCT03697278 -
Monitoring Postoperative Patient-controlled Analgesia (PCA)
|
N/A |