Acute Kidney Injury, Obesity
Conditions
Keywords
Gabapentin, Preoperative Medication, Obesity Surgery, AKI, Postoperative Complications, Bariatric Surgery, Laparoscopic Sleeve Gastrectomy, Kidney stress
Brief summary
This study evaluated the effect of a single preoperative dose of gabapentin on renal stress and kidney function following laparoscopic sleeve gastrectomy in adults with severe obesity. Sixty participants undergoing laparoscopic sleeve gastrectomy were randomized in a 1:1 ratio to surgery without preoperative gabapentin or surgery after a single 1200-mg oral dose of gabapentin. An additional 30 non-operative participants with severe obesity served as a non-randomized external reference cohort. Renal assessment included conventional kidney function markers and biomarkers, including Dickkopf-3 (DKK3) and neutrophil gelatinase-associated lipocalin (NGAL). The prespecified primary endpoint was urinary DKK3 concentration at 24 hours postoperatively.
Detailed description
Obesity is an important risk factor for kidney disease because it is strongly associated with diabetes and hypertension, two major causes of end-stage kidney disease (ESKD). Adults with severe obesity are at increased risk of diabetes compared with lean individuals. Laparoscopic sleeve gastrectomy (LSG) is an established surgical treatment for obesity and obesity-related diseases. Acute kidney injury (AKI) is an important postoperative complication associated with prolonged hospital stay, increased hospital costs, higher mortality, and an increased risk of subsequent chronic kidney disease. Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used postoperatively and may contribute to renal adverse effects in susceptible patients. Gabapentin is an anticonvulsant widely used for neuropathic pain and has also been investigated in the perioperative setting for reducing postoperative pain and opioid requirements. Experimental studies have suggested that gabapentin may influence pathways related to oxidative stress and renal injury; however, its effects on perioperative renal stress in clinical settings remain uncertain. Neutrophil gelatinase-associated lipocalin (NGAL) and Dickkopf-3 (DKK3) were evaluated as biomarkers of renal stress and kidney injury. NGAL has been investigated as an early biomarker of AKI, whereas urinary DKK3 has been proposed as a marker of renal tubular stress and risk of kidney injury. The study included 90 participants. Sixty participants undergoing LSG were randomized in a 1:1 ratio to LSG without preoperative gabapentin or LSG after a single 1200-mg oral dose of gabapentin approximately 1 hour preoperatively. An additional 30 participants with severe obesity who did not undergo surgery served as a non-randomized external reference cohort. Blood and urine samples were obtained at baseline, 24 hours postoperatively, and 6 months after surgery in the randomized surgical groups, whereas the external reference cohort underwent a single assessment at enrollment.
Interventions
PROCEDURELaparoscopic Sleeve Gastrectomy
Standard laparoscopic sleeve gastrectomy performed under general anesthesia according to institutional protocol, with gastric resection over a calibration bougie.
A single oral dose of 1200 mg gabapentin administered approximately 1 hour prior to induction of anesthesia for laparoscopic sleeve gastrectomy.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor was blinded to treatment allocation in the two randomized surgical groups. Participants and care providers were not blinded because no placebo was used.
Intervention model description
Participants were enrolled into three study groups. Sixty participants undergoing laparoscopic sleeve gastrectomy were randomized in a 1:1 ratio to Group II (LSG without preoperative gabapentin; n = 30) or Group III (LSG after a single 1200-mg oral dose of gabapentin approximately 1 hour preoperatively; n = 30). Group I comprised 30 participants with severe obesity who did not undergo surgery and served as a non-randomized external reference cohort.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-65 years old. * Participants with severe obesity (BMI ≥40 kg/m², without comorbidities or BMI ≥35 kg/m², in the presence of obesity-related comorbidities). * Preserved kidney function at baseline. * For the randomized surgical cohort (Groups II and III), participants with severe obesity scheduled to undergo laparoscopic sleeve gastrectomy. * For the non-randomized external reference cohort (Group I), participants with severe obesity who did not undergo laparoscopic sleeve gastrectomy during the study period or receive the study intervention. * Both sexes.
Exclusion criteria
* Advanced cancer receiving active treatment. * End-stage renal, hepatic, or cardiopulmonary disease. * Untreated schizophrenia or cognitive impairment. * Use of psychiatric medications, as specified in the study protocol. * Active substance abuse. * Chronic use of gabapentin or known hypersensitivity to gabapentin. * Pregnancy or breastfeeding. * Use of medications that could interfere with the assessed study parameter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Dickkopf-3 (DKK3) concentration | Baseline, 24 hours postoperatively, and 6 months after surgery | Urinary DKK3 was measured by ELISA at baseline, 24 hours postoperatively, and 6 months after surgery. The prespecified primary endpoint was the 24-hour postoperative urinary DKK3 concentration, with the primary comparison performed between the two randomized surgical groups (Group II and Group III) after adjustment for baseline urinary DKK3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Dickkopf-3 concentration | Baseline, 24 hours postoperatively, and 6 months after surgery | Serum DKK3 concentration was measured by ELISA as a biomarker of renal stress. |
| Serum neutrophil gelatinase-associated lipocalin (NGAL) concentration | Baseline, 24 hours postoperatively, and 6 months after surgery | Serum NGAL concentration was measured by ELISA as a biomarker of acute kidney injury. |
| Serum creatinine (SCr) concentration | Baseline and 24 hours postoperatively | Serum creatinine (SCr) was measured to assess kidney function in the randomized surgical groups. |
| Blood urea nitrogen (BUN) concentration | Baseline and 24 hours postoperatively | Blood urea nitrogen (BUN) was measured as a conventional marker of kidney function in the randomized surgical groups. |
| Estimated glomerular filtration rate (eGFR) | Baseline and 24 hours postoperatively | Estimated glomerular filtration rate (eGFR) was calculated from serum creatinine using the 2021 CKD-EPI creatinine equation to assess kidney function. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORKholoud Salah Ibraahim Amin, Bsc.
Delta university for Sciences and Technology
Outcome results
None listed