There are about 5618 clinical studies being (or have been) conducted in India. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Consecutive patients with cirrhosis and septic shock with AKI who give written informed consent will be included in this prospective trial. At baseline NT-Pro BNP, urine N-GAL will be done for all patients. A baseline serum blood sample (10 ml) and urine sample will be stored. Septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also be done. Patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease on hemodialysis, patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group, patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.
In children fluids are supplemented during surgery to provide volume, to maintain blood glucose levels, electrolyte balance and to meet the ongoing fluid losses during surgery. Fluid replacement during surgery since decades has been based on the Holliday and Segar method.These authors proposed that water maintenance in children includes: 100 millilitre (ml)/100 kilocalorie (kcal) for the first 10 kg of body weight, 50mL/100 kcal for 11-20 kg and 20mL/100 kcal for every kilogram of body weight above 20 kg. The maintenance electrolyte requirements of 3 mEq/100 kcal for sodium and 2 mEq/100 kcal for potassium per day, were based upon the electrolyte composition of breast and cow's milk. Based on these recommendations hypotonic fluid (0.45% saline) was considered as the ideal fluid for maintenance in children undergoing surgery. Since the past many years there have been many documented cases of hyponatremia after administration of hypotonic fluids with potential for serious neurological injury in this group of patients.The use of Holliday and Segar's formula to calculate the maintenance fluid regimen in postoperative children leads to an overestimation of the volume of fluid needed, as there is a low urine output in this period. The postoperative period is at risk for non-osmotic secretion of anti-diuretic hormone (ADH), which reduces the ability of kidney to excrete free water and carries risk for development of hyponatraemia.Authors in favour of hypotonic solutions feel that hyponatremia results from excessive volume of fluid and isotonic solutions have risk of hypernatremia, interstitial fluid overload, excessive sodium excretion, and hyperchloremic metabolic acidosis. Based on the increased incidence of hyponatremia in children undergoing surgery, the paediatric anaesthesia societies [Society of Paediatric Anesthesia (SPA), Paediatric Anaesthesia Society of Great Britain and European society of Paediatric Anesthesia (ESPA)] put forward guidelines for the type and amount of fluid to be administered during surgery.Since then normal saline is the commonly used fluid during the perioperative period.However recent studies have shown that the use of normal saline is associated with development of hyperchloremic metabolic acidosis and poor outcome. Ringer lactate (RL) is a commonly used intravenous fluid during surgery and has been found to have decreased possibility of producing hyponatremia although it is a slightly hypotonic solution.Plasmalyte is an isotonic fluid which has been shown to maintain electrolyte balance and prevent hyponatremia as well as hyperchloremic acidosis in adult population.However plasmalyte has been less frequently used in paediatric population.Therefore this study is planned with the aim of comparing intravenous fluids, ringer lactate and plasmalyte in the perioperative period regarding the incidence of hyponatremia produced by these solutions, their effect on electrolytes and blood gases in children undergoing elective surgery.
Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.
The goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in children.
This trial will study the effect of a polyherbal capsule in lowering the viral load of patients with chronic Hepatitis B infection and record the incidence of from Hepatitis B surface antigen elimination in 12 months
A prospective observational study using an interrupted time-series design to evaluate the effect of pre-hospital notification on trauma patients arriving at a trauma centre by ambulance, in India
Locally advanced Gall bladders cancers not amenable for curative resection are often treated with chemotherapy alone which is the current standard of care. Randomized trials have shown survival benefit with combination chemotherapy in gallbladder cancers. Gallbladder cancer is not common western world and thus there is lack of evidence regarding the impact of neoadjuvant or concurrent chemo-radiation in this cancer.Use of neoadjuvant treatment with chemotherapy alone or chemoradiotherapy has shown to downsize these tumors to safely undergo R0 resection in few published studies. Also if the patients develop distant metastasis during this neoadjuvant therapy they can be spared of unnecessary surgery. In a pilot study of 28 patients by Engineer et al conducted at Tata Memorial centre treated with neoadjuvant concurrent chemoradiation the investigators could achieve R0 resectability rate 0f 47% with a median overall survival (OAS) and progression free survival (PFS) of 35 and 20 months for the patients undergoing R0 resection. In this study the investigators intend to compare the effects of using neoadjuvant chemotherapy alone vs. neoadjuvant chemoradiation and chemotherapy for locally advanced gall bladder cancers in terms of down staging and overall survival.
This is a prospective, single-arm, multi-center, international, open-label, non-randomized, clinical study. The aim of the study is to assess the safety and efficacy of the use of the Hairstetics hair implant device in subjects affected with hair loss.
Propofol is an intravenous anaesthetic agent used for both induction and maintenance of anaesthesia. An important adverse effect is the significant fall in blood pressure. The current clinical study will be done to determine the efficacy of leg elevation and wrapping in reducing the incidence and severity of propofol induced hypotension in patients undergoing general anaesthesia.
This study evaluates the effect of per-operative music on the bio-molecular inflammatory response in laparoscopic surgery. Per-operative music intervention will be given to the test group via headphones while the control group will be applied headphones without any music (Silent). The inflammatory stress response will be measured postoperatively at 6 hours and 24 hours postoperatively along with the baseline levels measured preoperatively. The values will be compared between the test and control groups.