The Efficacy of Oral Melatonin Attenuating Renal Ischaemia-Reperfusion Injury in Abdominal Aortic Aneurysm Surgery: A Randomized Controlled Trial

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220720006

Enrollment

Registered

2022-07-20

Start date

2022-07-25

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Increased oxidative stress and inflammatory response during abdominal aortic aneurysm repair surgery melatonin, Abdominal aortic aneurysm, abdominal aortic aneurysm repair, oxidative stress, inflammatory response, Ischemia reperfusion Injury, renal ischemia reperfusion injury, acute kidney injury

Interventions

Take oral melatonin 10 mg per days for 3 days before surgery and continue take oral melatonin 10 mg per days for 3 days postoperatively,no intervention group

Experimental Drug,No Intervention No treatment

Melatonin,Control

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. All patients above 18 years old 2. Patients are diagnosed abdominal aortic aneurysm and eligibility to elective abdominal aortic aneurysm surgery

Exclusion criteria

Exclusion criteria: 1.The patients with history of regular taking melatonin 2.The patients with known melatonin hypersensitivity or allergy 3.The patients with emergency abdominal aortic aneurysm repair who are not able to take pre-operative oral melatonin 4.The patients who cannot inform consent 5.The patients have absolute NPO

Design outcomes

Primary

Measure	Time frame
Acute kidney injury Within 24 hours after surgery KDICO criteria, NGAL level	—

Secondary

Measure	Time frame
Abdominal compartment syndrome Within 24 hours after surgery Intraabdominal pressure with World Society of the Abdominal Compartment Syndrome (WSACS) consensus criteria,Acute lung injury Within 24 hours after surgery The American-European Consensus Conference on ARDS criteria,Acute limb compartment syndrome Within 24 hours after surgery Clinical diagnosis,30 days mortality within 30 days after surgery Patient reported outcome using follow up status,Length of hospital stay Depend on hospital stay time each patients Length of hospital stay (day),Difference of NGAL level within 24 hours after surgery preoperative, Intraoperative and postoperative NGAL level ,Difference of BUN/Cr ratio within 24 hours after surgery preoperative, Intraoperative and postoperative BUN/Cr level,Difference of creatinine clearance within 24 hours after surgery preoperative, Intraoperative and postoperative creatinine clearance level,24-hr urine volume within 24 hours after surgery postoperative urine volume(ml),Perioperative myocardial infarction within 24 hours after surgery preoperative, Intraoperative and postoperative Trop-I level, ECG deviation,Difference of Total CK within 24 hours after surgery preoperative, Intraoperative and postoperative total CK level,Difference of blood lactate within 24 hours after surgery preoperative, Intraoperative and postoperative blood lactate,Difference of LDH within 24 hours after surgery preoperative, Intraoperative and postoperative LDH level,Difference of CRP within 24 hours after surgery preoperative, Intraoperative and postoperative CRP level,Difference of ESR within 24 hours after surgery preoperative, Intraoperative and postoperative ESR level,Difference of IL-6 within 24 hours after surgery preoperative, Intraoperative and postoperative IL-6 level	—

Measure

Time frame

Abdominal compartment syndrome Within 24 hours after surgery Intraabdominal pressure with World Society of the Abdominal Compartment Syndrome (WSACS) consensus criteria,Acute lung injury Within 24 hours after surgery The American-European Consensus Conference on ARDS criteria,Acute limb compartment syndrome Within 24 hours after surgery Clinical diagnosis,30 days mortality within 30 days after surgery Patient reported outcome using follow up status,Length of hospital stay Depend on hospital stay time each patients Length of hospital stay (day),Difference of NGAL level within 24 hours after surgery preoperative, Intraoperative and postoperative NGAL level ,Difference of BUN/Cr ratio within 24 hours after surgery preoperative, Intraoperative and postoperative BUN/Cr level,Difference of creatinine clearance within 24 hours after surgery preoperative, Intraoperative and postoperative creatinine clearance level,24-hr urine volume within 24 hours after surgery postoperative urine volume(ml),Perioperative myocardial infarction within 24 hours after surgery preoperative, Intraoperative and postoperative Trop-I level, ECG deviation,Difference of Total CK within 24 hours after surgery preoperative, Intraoperative and postoperative total CK level,Difference of blood lactate within 24 hours after surgery preoperative, Intraoperative and postoperative blood lactate,Difference of LDH within 24 hours after surgery preoperative, Intraoperative and postoperative LDH level,Difference of CRP within 24 hours after surgery preoperative, Intraoperative and postoperative CRP level,Difference of ESR within 24 hours after surgery preoperative, Intraoperative and postoperative ESR level,Difference of IL-6 within 24 hours after surgery preoperative, Intraoperative and postoperative IL-6 level

—

Countries

Thailand

Contacts

Public ContactPongpit Pongsanon

Faculty of Medicine, Chiang Mai University

phongphitpp@gmail.com0896885169

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026