Impact of low sodium levels on recovery after major cancer surgeries
Impact of Peri-Operative Hyponatremia on Postoperative Outcomes in Major HPB Surgeries for Cancers
This study looks at how low sodium levels before and after major cancer surgeries affect recovery and complications in patients undergoing these procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, Delhi) |
| Trial ID | NCT06475911 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate how perioperative hyponatremia, defined as sodium levels below 135 mmol/L, affects postoperative outcomes in patients undergoing major hepatobiliary-pancreatic surgeries for cancer. It will compare the rates of major complications and early mortality within 90 days post-surgery between patients with and without hyponatremia. The study will include both retrospective data from 2010 and prospective data collection until June 2024, assessing long-term outcomes such as overall survival and disease-free survival. Statistical analyses will be performed to determine the significance of the findings.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing major hepatobiliary-pancreatic surgeries for cancer at the Institute of Liver and Biliary Sciences.
Not a fit: Patients with diuretic-induced hyponatremia or those who have not had a preoperative serum sodium level recorded may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at higher risk for complications after major cancer surgeries, leading to improved management strategies.
How similar studies have performed: While the specific impact of perioperative hyponatremia on postoperative outcomes in major HPB surgeries is less explored, similar studies have shown that electrolyte imbalances can significantly affect surgical recovery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. All patients undergoing major HPB cancer surgeries at ILBS from 2010 till 30th June 2024. Exclusion Criteria: 1. Presence of diuretic (Thiazide, Frusemide), pain killer (Indomethacin, Ketorolac) induced preoperative hyponatremia. 2. Patients with peri-operative diarrhea and vomiting due to infective cause leading to hyponatremia. 3. Patients who did not have a preoperative serum sodium level recorded within 72 hours prior to surgery. 4. Minor HPB cases.
Where this trial is running
New Delhi, Delhi
- Institute of Liver and Biliary Sciences — New Delhi, Delhi, India (Recruiting)
Study contacts
- Study coordinator: Dr Sambhav Gupta, MS
- Email: drsambhavgupta@gmail.com
- Phone: 01146300000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.