T.V Challenge to Predict Early Post- Operative Acute Kidney Injury and Intra-operative Hypotension in Laparoscopic Abdominal Surgeries

NCT05301582 | Completed DMC

• 1 other identifier: M.D- 302-2021
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of study is to verify the predictability of TV Chalange test during laparoscopic abdominal surgery for early postoperative AKI and intra-operative hypotension. .

Conditions

Tidel Volume Challenge Test

Outcome Measures

Primary Outcomes (1)

• The sensitivity of TVC test to predict early post-operative AKI in laparoscopic surgeries.

  The sensitivity of TVC test to predict early post-operative AKI in laparoscopic surgeries.

  Through Study Completionan average of 24 hours

Secondary Outcomes (4)

• The sensitivity of TVC test to predict intraoperative post insufflation and desufflation hypotension.

  Through Study Completionan average of 24 hours

• The relationship between exposure index (the product of inflation time x intra-abdominal pressure) and early post-operative AKI.

  Through Study Completionan average of 24 hours

• The incidence of AKI in laparoscopic surgeries.

  Through Study Completionan average of 24 hours

• The ability of (uNGAL) to predict early post operative AKI.

  Through Study Completionan average of 24 hours

Study Arms (1)

Group

A total of 70 consecutive adult patients, aged 18-65 years scheduled for elective laparoscopic surgery under general anesthesia will be included in the study.

Diagnostic Test: Tidal volume challenge test

Interventions

Tidal volume challenge test DIAGNOSTIC_TEST

The purpose of our study is to verify the predictability of TVC test during laparoscopic abdominal surgery for early postoperative AKI and intra-operative hypotension.

Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted in Kasr Alainy Hospital of Cairo University.

You may qualify if:

• Gender both males and females
• ASA Class I and II
• Age 18-65 years
• Patients undergoing elective laparoscopic surgery under general anaesthesia

You may not qualify if:

• Kidney dysfunction
• Cardiac arrhythmias and valvular heart disease
• Chronic obstructive pulmonary disease
• Right ventricular failure
• Intracranial hypertension
• Airway asthma or a long history of smoking
• Those who are on NSAID for 1 week prior to surgery.

Sponsors & Collaborators

• Cairo University: lead
• Hala Mostafa Gomaa: collaborator
• Ahmed Mohamed Ahmed Mostafa: collaborator
• Mohamed Abdel Ghany Ali Elshazly: collaborator

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

Study Officials

• Ahmed A Mohamed, M.D

  Cairo University

  PRINCIPAL INVESTIGATOR

• Hala M Gomaa, M.D

  Cairo University

  PRINCIPAL INVESTIGATOR

• Mohamed A Ali Elshazly, M.D

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Study Record Dates

• First Submitted: February 12, 2022
• First Posted: March 29, 2022
• Study Start: January 1, 2022
• Primary Completion: May 16, 2022
• Study Completion: May 18, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

EG (1)